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<h3>Job Description</h3>
Job Description
The Automation Support Engineer within the R&amp;D Production Engineering Group contributes to the support, development, and implementation of automation systems and workflows to support the processing of samples in R&amp;D and clinical diagnostics laboratory environments. This individual collaborates with a team of scientists and engineers on prioritization and support of a fleet of automated liquid handlers. There will also be project opportunities to conceptualize, design, develop, implement and support solutions designed to optimize the performance and increase the efficiencies of the laboratory processes.
PRIMARY RESPONSIBILITIES:
<ul>
<li>Support liquid handling robots.</li>
<li>Build knowledge on hardware and software on multiple types of laboratory automated liquid handlers, such as Tecan Fluent, Hamilton STAR and Vantage, and Beckman i7, among others</li>
<li>Build rapport with end-users, and coordinate with cross-functional teams</li>
<li>Prepare documentation for equipment qualification and operating procedures to ensure successful implementation in the labs</li>
<li>Prepare User Requirement and Testing Procedure, Standard Operating Procedures, and related documentations</li>
<li>Oversee the functional and validation testing, IQ/OQ/PQ </li>
<li>Additional responsibilities include user training, troubleshooting, and on-going support for the end-users</li>
</ul>
QUALIFICATIONS:
<ul>
<li>BS degree in Biomedical engineering, closely related scientific field, or equivalent; MS degree preferred</li>
<li>2+ years of laboratory automation engineering experience required</li>
<li>Technical proficiency and experience in automation and systems development and integration for the life science industry; especially with robotics and liquid handling systems</li>
<li>Experience in computer programing is required</li>
</ul>
KNOWLEDGE, SKILLS, AND ABILITIES:
<ul>
<li>Strong project management skills, organizational skills, and written and verbal communication skills are required</li>
<li>Flexibility and self-initiative required to support several simultaneous automation projects</li>
<li>Biotech, pharmaceutical, Lab automation providers, or clinical-laboratory experience is highly desirable</li>
</ul>
#LI-TH1 #LI-OnsiteThe pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years &amp; depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Austin, TX$95,500—$119,400 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit <a href="http://www.natera.com" target="_blank">www.natera.com</a>.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents. 
Link: <a href="https://www.natera.com/notice-of-data-collection-california-residents/" target="_blank">https://www.natera.com/notice-of-data-collection-california-residents/</a>
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Automation Support Engineer

<h3>Job Description</h3>
Job Description
 
Engineer, Manufacturing

Position Summary
The Manufacturing Engineer will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards. This role will also recommend and implement improvements to production processes, methods, and controls and coordinate manufacturing launch for new or revised products. This role will support daily management activities to ensure commitments are achieved and communicated to the customer support teams. 
 
US CITIZENSHIP IS REQUIRED FOR THIS ROLE
Principle Responsibilities
<ul>
<li>Develops and implements optimized and cost-effective manufacturing processes and inspection methods (as applicable), in accordance with product specifications and quality standards. </li>
<li>Develops overall engineering project strategies and timelines, including critical path identification and project risks.</li>
<li>Recommends and implements improvements to production processes, assembly methods, and controls by utilizing Lean Manufacturing and Six Sigma tools. </li>
<li>Collaborates with other departments for product tooling, gauging and fixtures design to ensure production methods are robust in support of reducing cost of poor quality and implementing standard work. </li>
<li>Supports creation of PFMEAs, control plans, process flow documents, contact material documents, and other related manufacturing documentation. </li>
<li>Estimates resource requirements, production times, and relative costs to provide data for operational decision-making and to provide data for new program proposals.</li>
<li>Provides design for manufacturing (DFM) feedback for all products, both new and sustaining.</li>
<li>Participates in the engineering change notice process and contract review process for the engineering team to ensure timely release of engineering changes and customer orders.</li>
<li>Utilizes SolidWorks, NX, or other 3D Modeling software to create and/or modify process drawings.</li>
<li>Works closely with cross-functional departments to develop, coordinate, and implement technical training for employees. </li>
<li>Provides engineering support to the production department to troubleshoot and resolve technical problems </li>
<li>Provides support for CNC programming activities.</li>
<li>Further develop and refine Engineering departmental standards and best practices.  </li>
<li>Supports organization and site policies and procedures, goals and objectives, applicable regulations, and good manufacturing practices.</li>
<li>As applicable, read, analyze, and interpret general business periodicals, professional journals, technical procedures, industry standards and governmental regulations.   </li>
<li>Addresses customers’ issues and improves performance, appearance, and impact of product on the end-user.</li>
<li>Provides support to manufacturing, marketing, and customer service, interfaces with customers and suppliers.</li>
<li>Applies critical thinking skills to solve practical problems that incorporate a variety of inputs in multi-variable scenarios. </li>
<li>Performs other duties or special projects as required or as assigned by supervisor.</li>
</ul>
Qualification Requirements
Credentials/Experience:
<ul>
<li>Bachelor's degree in engineering (biomedical engineering, mechanical engineering, manufacturing engineering, industrial engineering, material sciences) or an engineering technical field is required. Training in a manufacturing environment with equivalent combination of education and experience will be considered.</li>
<li>2+ years of experience in similar manufacturing / engineering position or equivalent.</li>
<li>2+ years’ experience in CNC machining and/or other manufacturing processes.</li>
<li>Demonstrated engineering experience in a high precision machine shop and/or assembly environment with moderate to high complexity products.</li>
<li>Experience and demonstrated proficiency in the use of Mastercam, Solidworks, CREO/ProE or other CAD/CAM software. </li>
</ul>
Experience/Educational/Training Preferred:
<ul>
<li>Experience in aerospace and defense manufacturing is highly preferred.</li>
<li>Secondary processes experience (welding, brazing, polishing, passivation, heat treat, assembly) desired</li>
</ul>
Knowledge, Skills, and Abilities: 
<ul>
<li>Strong interpersonal skills: Ability to relate to and work with diverse groups of people. Coordinates project activities and resolves individual conflicts and issues. Handles sensitive and confidential situations and materials.</li>
<li>Strong working knowledge of manufacturing methods, processes (i.e. machining methods, forging process, automation, heat treat methods, finishing, and polishing, material handling, basic machine design and metal fabrication. </li>
<li>Understanding of GD&amp;T and fundamental engineering principles</li>
<li>Good knowledge of lean manufacturing principles and ability to implement of Lean and Six Sigma techniques in business and manufacturing systems</li>
<li>Ability to develop collaborative relationships with customers, vendors, and team members within the organization. </li>
<li>Teamwork: Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals.</li>
<li>Demonstrated organizational skills with the ability to handle and prioritize multiple projects/tasks simultaneously in a timely manner in a fast-paced environment.</li>
<li>Possess engineering, analytical and problem-solving skills</li>
<li>Proficient in modern computer aided design (CAD) software, Solidworks or NX preferred</li>
<li>Proficient in modern computer aided manufacturing (CAM) software such as MasterCam</li>
<li>Knowledge of applicable regulatory requirements and concepts including ISO 13485, ISO 14971, MDR 2017/745, CAPA, NCR, supplier control, manufacturing control, design control.</li>
<li>Knowledge of Design of Experiments, Control Plans, PFMEA, DMAIC Model. </li>
<li>Sound written and oral communication skills. Ability to provide written and/or oral communication to management and technical staff audiences.</li>
<li>Excellence in Microsoft Word, Excel, and PowerPoint</li>
<li>Ability to prioritize and work independently with a sense of urgency</li>
</ul>
Other Requirements 
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements
While performing the duties of this job, the employee could be required to stand. The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision, and ability to adjust focus. 
Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.
 
Equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities

Engineer, Manufacturing

<h3>Job Description</h3>
Job Description
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines &amp; Values:
<ul>
<li>We empower and support our colleagues</li>
<li>We commit to client success at every turn</li>
<li>We have the courage to do the right thing</li>
<li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li>
<li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li>
</ul>

Responsibilities:
Entry level Project Engineer position in the Pharma industry. Client will train the resource on Customer Complaint Investigation.

Requirements:
<ul>
<li>Deviation or customer complaint investigation remediation experience is a plus but is not necessary.</li>
<li>Undergraduate Engineering/STEM degree required (mechanical, chemical, biomedical, etc.).</li>
<li>0-3 years experience. Some Pharma experience preferred but not absolutely required.</li>
<li>Proficiency using PC and Microsoft Office tools.</li>
<li>Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.</li>
<li>Ability to work as part of a team.</li>
<li>Strong problem-solving and critical thinking skills.</li>
<li>Excellent organizational and time management skills.</li>
<li>Strong attention to detail</li>
<li>Strong interpersonal skills and clear communication capabilities.</li>
<li>Experience with and tolerance for high levels of challenge and change.</li>
</ul>
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
National (US) Range$70,491—$73,000 USD
Benefits
Why Choose Verista?
<ul>
<li>High growth potential and fast-paced organization with a people-focused culture</li>
<li>Competitive pay plus performance-based incentive programs</li>
<li>Company-paid Life, Short-Term, and Long-Term Disability Insurance.</li>
<li>Medical, Dental &amp; Vision insurances</li>
<li>FSA, DCARE, Commuter Benefits</li>
<li>Supplemental Life, Hospital, Critical Illness and Legal Insurance</li>
<li>Health Savings Account</li>
<li>401(k) Retirement Plan (Employer Matching benefit)</li>
<li>Paid Time Off (Rollover Option) and Holidays</li>
<li>As Needed Sick Time</li>
<li>Tuition Reimbursement</li>
<li>Team Social Activities (We have fun!)</li>
<li>Employee Recognition</li>
<li>Employee Referral Program</li>
<li>Paid Parental Leave and Bereavement</li>
</ul>
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. 
For more information about our company, please visit us at Verista.com

5667- Complaint Investigator / Project Engineer

<h3>Job Description</h3>
Job DescriptionSage Product Development, Inc. Senior Product Development Engineer&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; Reports To:&nbsp; Engineering Manager&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; COMPANY OVERVIEW: Sage Product Development, Inc. provides fast, efficient and creative product development services to medical device companies.&nbsp; We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between. We combine a high level of experience with a low overhead company structure. We solve client companies’ technical challenges and meet their product development needs in a timely, efficient and highly personalized manner. We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their product development engineering abilities, and build their network within the industry. GENERAL SUMMARY: 
<ul>
<li>Develop medical devices from concept through market introduction on a contract basis for client companies.</li>
<li>Meet or exceed customer expectations.</li>
</ul>
 ESSENTIAL JOB FUNCTIONS (all as required by client companies): 
<ul>
<li>Manage product development projects. Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Proactively communicate task assignments to responsible individuals, and ensure that tasks are completed within the planned time. Track projects to project plans. Proactively report project status to Sage personnel and to the project’s client company.</li>
<li>Generate project timing and expense estimates and prepare project proposals for client companies.</li>
<li>Design and develop medical devices (disposable and reusable), catheters, equipment, implants, and/or packaging, from concept through market introduction. Ensure that designs meet performance specifications, regulatory and manufacturing requirements.</li>
<li>Interact with client companies in a professional manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.</li>
<li>Generate innovative concepts for new medical device designs to satisfy customer and clinical requirements. Lead and participate in concept generation activities, including brainstorming sessions. Refine, rate, rank and/or otherwise assess concepts.</li>
<li>Utilize SolidWorks to develop detailed 3-D CAD models and drawings, including component, subassembly, and top-level drawings.</li>
<li>Investigate and evaluate existing technology for application to projects.</li>
<li>Design and implement new methodologies, materials, machines, processes or products as required to achieve product development goals.</li>
<li>Produce prototype devices for testing and evaluation. Work with internal and/or external resources to produce prototype device components. Assemble and/or evaluate prototype devices.</li>
<li>Conduct bench and/or animal feasibility studies.</li>
<li>Conduct product verification and validation testing to demonstrate product safety and efficacy. Determine what testing is required to satisfy product requirements, to investigate potential failure modes, and to otherwise address the project design inputs. Develop protocols, plan testing, and perform or monitor testing. Utilize statistical methods as required to plan testing and to analyze test results. Write test reports which draw conclusions from the results.</li>
<li>Conduct risk analyses. Conduct and document Failure Mode and Effects Analyses.</li>
<li>Perform tolerance analysis of components and assemblies to ensure proper fit and functionality.</li>
<li>Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet customer expectations.</li>
<li>Maintain detailed essential product and process documentation throughout all phases of research and development. Maintain Design History Files (DHFs). Ensure that DHFs are accurate, complete and well organized.</li>
<li>Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.</li>
<li>Ensure that all work satisfies the requirements of client companies’ Quality Systems, with particular emphasis on Design Control.</li>
<li>Conduct and document Design Reviews.</li>
<li>Participate in Material Review Board activities. Make decisions regarding product and material discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies.</li>
<li>Date, sign and have witnessed all documents that may establish inventorship dates.</li>
<li>Some local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).</li>
</ul>
 OTHER DUTIES AND RESPONSIBILITIES 
<ul>
<li>Any other duties as assigned.</li>
</ul>
 REQUIRED COMPETENCIES Customer Focus 
<ul>
<li>Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner.</li>
</ul>
Management of Resources 
<ul>
<li>Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.</li>
</ul>
 Communication Skills 
<ul>
<li>Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.</li>
</ul>
 PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES: 
<ul>
<li>Bachelor's degree in Mechanical or Biomedical Engineering is required. Master’s degree in engineering, management or business is a plus.</li>
<li>Some prior medical device product design and development experience is required.</li>
<li>Demonstrated ability to bring products from concept to market.</li>
<li>Ability to interact with client companies in a professional manner.</li>
<li>SolidWorks 3D CAD proficiency is required.</li>
<li>Knowledge of probability and statistics.</li>
<li>Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.</li>
<li>Familiarity with FDA QSR and ISO 13,485 medical device regulations.</li>
<li>Depth of knowledge in one or more clinical areas.</li>
<li>Depth of knowledge in one or more medical device product areas.</li>
<li>Depth of knowledge in one or more technical areas, for example finite element analysis.</li>
</ul>
&nbsp;SUPERVISORY RESPONSIBILITY: 
<ul>
<li>May direct the work of other people, and may have direct reports.</li>
</ul>
&nbsp;WORKING CONDITIONS/PHYSICAL DEMANDS: 
<ul>
<li>Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery and tools. Must be able to lift more than 50 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in a laboratory environment.</li>
<li>The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.</li>
<li>External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.</li>
</ul>
 TRAINING: 
<ul>
<li>Training requirements are defined in the Sage Training Log.</li>
</ul>

Senior Product Development Engineer

<h3>Job Description</h3>
Job Description
We are seeking an experienced Equipment Engineer / Senior Equipment Engineer at our Germantown, MD location to join us in our mission to serve patients with our next generation of innovative Gene Therapies. This position will require a professional who is technically savvy, thrives in a dynamic team environment, poses exceptional problem-solving skills, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will provide Facility, Equipment, and Validation Engineering support to Precigen’s GMP Manufacturing, Quality Control (QC), and Research and Development (R&amp;D) facilities.
Duties and Responsibilities:
<ul>
<li>Oversee site Facility, Utility, and Equipment Maintenance Programs, coordinating with Metrology, Facilities, Validation, and User group personnel, as well as external vendors, to ensure the proper operation of Facility systems [e.g. Heating Ventilation and Air Conditioning (HVAC), Backup Power, Water Purification, Compressed Gas Distribution, Glass/Part Washers, Autoclaves, Refrigerator/Freezers], Process Equipment [e.g. Incubators, Tangential Flow Filtration (TFF), Fast Protein Liquid Chromatography (FPLC), and Centrifuges], and Analytical Equipment [e.g. Polymerase Chain Reaction (PCR), Environmental Monitoring Equipment, Cell Analysis, Spectrophotometers]. Hand-on troubleshooting, partnership with Original Equipment Manufacturer (OEM) or service vendors, as needed</li>
<li>Provide technical expertise to guide formation of calibration, qualification, and maintenance requirements for new site systems and update/improvement of existing equipment/utilities</li>
<li>Manage site Facility and Equipment drawings in Computer Aided Design (CAD) software</li>
<li>Author and Review Facility and Equipment Related Standard Operating Procedures (SOPs), Work Instructions (WI)</li>
<li>Author, Review, and Execution of Validation/Engineering Protocols/Reports, such as temperature mapping of Controlled Temperature Units (CTUs) and Autoclaves using KAYE validator or similar data logging equipment, Engineering studies, and IQ/OQ/PQ of facility, processing, and analytical equipment</li>
<li>Support site Quality Management System (QMS) through Authoring and Reviewing of Equipment/Facility related Change Controls, Deviations, and Corrective and Preventive Actions (CAPA)</li>
<li>Lead site Capital Expenditure (CAPEX) projects, coordinating with vendors, consultants, contractors to implement site upgrades</li>
<li>Partner with Safety Staff to ensure facility is maintained in a safe and compliant state</li>
</ul>
EDUCATION AND EXPERIENCE:
<ul>
<li>Bachelor’s degree in Chemical, Biomedical, Mechanical, Electrical Engineering or equivalent and Three (3) + years of Good Manufacturing Practice (GMP) experience (Level will be determined based on education and experience)</li>
<li>Demonstrated experience using engineering principles to troubleshoot and repair mechanical/electrical equipment.</li>
</ul>
<ul>
<li>Technical Writing Experience generating Standard Operating Procedures (SOP), Protocols/Reports, Work Instructions, and/or Maintenance Plans</li>
<li>Strong computer skills with Microsoft Office, Computerized Maintenance Management Systems(CMMS), Building Management/Automation Systems (BMS/BAS), Environmental Monitoring System(EMS), Validation Data Management Software, Computer Aided Design (CAD) and the ability to quickly learn new applications.</li>
</ul>
<ul>
<li>Ability to sit, stand, and walk regularly to access mechanical areas and aseptically gown into production suite. Able to maneuver equipment and supplies up to 40 pounds.</li>
</ul>

Equipment Engineer / Senior Equipment Engineer

<h3>Job Description</h3>
Job Description
Job Title: Reliability Performance Engineer
Location: Parkway Deerfield IL 
Duration: 12+ Months 
Description:
We are seeking a Reliability Performance Engineer to develop and execute testing documentation and scripts that validate and verify both physical and digital medical products.
This role will be responsible for designing, implementing, and managing test protocols that ensure product reliability, security, and performance under various conditions, including high-volume simulations, network interactions, and cybersecurity challenges.
The ideal candidate has a strong background in test automation, system validation, and compliance-driven testing within the medical device industry.
Key Responsibilities
• Create detailed test plans, scripts, and protocols to validate software, firmware, and hardware components of medical devices.
• Develop and automate tests that simulate high-volume data processing, real-world network interactions, and security threats.
• Conduct functional, integration, and system-level testing to ensure compliance with regulatory and industry standards.
• Perform manual and automated testing for both digital (software-based) and physical (hardware-based) products.
• Design and execute high-volume simulations to evaluate device performance under extreme workloads.
• Validate network reliability by simulating real-world connectivity scenarios, including cloud, IoT, and hospital network environments.
• Conduct cybersecurity testing, including penetration testing, encryption validation, and threat modeling.
• Analyze test results, identify failure points, and collaborate with R&amp;D, engineering, and security teams for issue resolution.
• Document testing methodologies, defects, and performance metrics in compliance with FDA, ISO 13485, IEC 62304, and HIPAA regulations.
• Support root cause analysis (RCA) and corrective/preventive actions (CAPA) based on test findings.
• Work closely with software developers, network engineers, and product designers to refine product testing approaches.
• Develop and maintain automated test frameworks for continuous integration/continuous deployment (CI/CD).
• Stay updated on medical device regulations, cybersecurity best practices, and emerging testing technologies.
Required:
• Bachelor’s or master’s degree in computer science, Electrical Engineering, Biomedical Engineering, or related field.
• 5+ years of experience in software/hardware testing, automation, or medical device validation.
• Strong knowledge of test scripting languages (Python, Java, C#, or similar).
• Experience with test management tools (e.g., TestRail, JIRA, Selenium, Appium, Cypress).
• Familiarity with network protocols, security testing, and performance benchmarking.
• Understanding of FDA 21 CFR Part 820, ISO 14971 (Risk Management), and IEC 60601 standards.
Preferred:
• Experience with cloud-based medical device testing (AWS, Azure, IoT platforms).
• Knowledge of cybersecurity frameworks (NIST, OWASP, FIPS 140-2).
• Certification in ISTQB, CISSP, or Certified Ethical Hacker (CEH).
Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs. Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities 
<h3>Company Description</h3>
Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

Reliability Performance Engineer

<h3>Job Description</h3>
Job Description
 
Quality Engineer
Reporting directly to the Quality Assurance and Lab Manager, this position uses critical thinking and technical writing skills to research, develop and document key quality processes such as process and software validations, procedures, risk assessments, PFMEAs, as assigned in a timely manner. This role supports all levels of operations, quality, laboratory, and engineering departments in the development, management and execution of testing and validation protocols. This position will service all aspects of the businesses at PCNA. This role supports the Engineering team with maintaining the facilities’ master validation plan. Facilitates the company’s Management of Change (MOC) process. Maintain outgoing process data for statistical analyses, trending purposes to ensure the process is maintained as validated. Continuous Improvement Coach and Coordinator. Perform data analyses using ERP, PowerBI, Excel, etc.
 
POSITION REQUIREMENTS
Education, Credentials, Licenses:
<ul>
<li>Bachelor’s degree in Engineering (Biomedical, Mechanical, etc), Science (Chemistry, Biology, Physics, etc.), or Math (Statistics) required</li>
</ul>
Kind &amp; Length of Experience:
<ul>
<li>Minimum of 5 years of experience in an industrial manufacturing environment with a quality system designed to meet the requirements of the FDA Quality System required</li>
<li>Proficient in Microsoft Office is required </li>
<li>GMP in Cosmetics or Pharmaceuticals experience is preferred</li>
<li>Certifications in quality, engineering, Six Sigma, or Lean Manufacturing are preferred</li>
<li>Experience with Microsoft Business Dynamics preferred </li>
<li>Experience with Power BI preferred</li>
</ul>
IV. PERFORMANCE MEASURES AND STANDARDS
Quality Improvement
<ul>
<li>Perform root cause investigation and CAPA (corrective action preventative action) to deliver non-repeatable issues, measure effective performance of CAPA solutions.</li>
<li>Develop, lead and drive optimization Kaizens related to top quality losses.</li>
<li>Lead data collection, analysis and assignment of standard Quality loss trees in support of operational KPI reporting.</li>
<li>Support the development of PFMEA documents, perform risk assessment and updated PFMEA documents for equipment and processes as needed.</li>
<li>Partner with department leaders to execute validations and provide support for validation including report writing, and participation.</li>
</ul>
ISO Documentation
<ul>
<li>Create new SOPs and modify current SOPs using the established structured format; which will allow for production operator to perform and produce the same outcome every time the process is executed.</li>
</ul>
ISO Management System
<ul>
<li>Leads, develops and manages the layered process audit program.</li>
<li>Manage and ensure compliance with the quality management system through communication, training and internal/external audits.</li>
<li>Assess training and development needs related to the quality program.</li>
<li>Ensure that all training activities associated with validation activities are performed in a timely manner.</li>
<li>Implement and verify site calibration and maintenance program for inspection, measuring and testing equipment. Coordinate performance of quality measurement equipment capabilities studies.</li>
<li>Initiate and support Management of Change (MOC) per requirements.</li>
<li>Support the documentation of maintenance procedures to ensure the production of quality products. Provide insights to trends and performance of processes through data analysis.</li>
<li>Support efforts to implement and maintain the all company certification and regulations including, SQF, ISO 9001, ISO/IEC 17025, and RC14001/EHS&amp;S management system; </li>
</ul>
Innovation
<ul>
<li>Support innovation funnel activities with key customers by partnering with process engineering and operations departments to support IQ/OQ/PQ processes.</li>
<li>Develop timely validation and test protocols for new processes, computer software, or equipment in conjunction with the engineering group.</li>
<li>Establish and maintain systems to maintain raw materials, finished goods within specification.</li>
<li>Supports and participates in structured quality improvement activities related to customers, consumer issues/complaints and PQ gaps.</li>
</ul>
Peter Cremer Training Required
<ul>
<li>We will follow the company written training program for this position.</li>
</ul>
Customer Service, Teamwork &amp; Code of Conduct 
<ul>
<li>Maintain a safe, legal and environmentally protective operation </li>
<li>Listen to our customers, suppliers and employees </li>
<li>Respond quickly to customer concerns </li>
<li>Follow set guidelines for GMP, quality and food safety requirements </li>
<li>Maintain training on applicable procedures in quality, GMP, and food safety </li>
<li>Report any food safety, security, and / or quality issues to management or the HACCP team to initiate action</li>
<li>Provide flexible and innovative strategies to support new business opportunities </li>
<li>Be cost effective in the utilization of our resources, thereby contributing to the profitability of Peter Cremer North America, LP and our customers </li>
<li>Strive for continued improvement </li>
<li>Willing and eagerness to learn</li>
<li>Maintain positive attitude.</li>
</ul>
We are an equal opportunity employer. Applicants are considered for positions without regard to sex, race, color, ancestry, religion, national origin, disability, age, marital status, disabled veteran or Vietnam era veteran status, genetic information, sexual orientation, pregnancy, including childbirth or any related condition, gender identity or expression, citizenship, or any other characteristic protected by applicable state, federal or local laws.

Quality Engineer

<h3>Job Description</h3>
Job DescriptionCompany Description 
At ForTec, we offer an independent work environment, training on the top medical technologies, and interaction&nbsp;with physicians and medical professionals. We provide our employees with a generous benefits package including:&nbsp;
<ul>
<li>Competitive bi-weekly salary with bonus structure</li>
<li>401k plan with generous company match</li>
<li>Annual Profit-Sharing opportunity</li>
<li>Employee Referral Bonuses</li>
<li>Service Awards</li>
<li>Generous PTO allowance</li>
<li>7 Company Paid Holidays PLUS 1 Floating Holiday&nbsp;</li>
<li>Medical, dental, vision, disability, and life insurance</li>
<li>Health and Wellness Rewards Program</li>
</ul>
Join our company – you CAN make a difference
Job Description 
Our continued growth and success has allowed us to provide exciting career opportunities for passionate, customer focused, and highly motivated individuals.&nbsp; We&nbsp;are currently seeking a Field Service Engineer to join our team.&nbsp; This is a great opportunity for someone with medical equipment service experience who enjoys working independently and contributing your skills to ensure we deliver the highest quality mobile surgical technology solutions to our clients.
Primary Responsibilities:
<ul>
<li>Maintain, repair&nbsp;and calibrate&nbsp;surgical lasers</li>
<li>Visually inspect, repair&nbsp;and perform&nbsp;calibration on equipment; ensure&nbsp;safety, proper operation, physical completeness and aesthetically pleasing exterior of equipment prior to releasing the machine for use</li>
<li>Perform&nbsp;preventative maintenance on all equipment, ensuring optimal operation</li>
<li>Inventory&nbsp;and order&nbsp;repair parts, and ensure&nbsp;back up supplies are available for efficient repair of equipment</li>
<li>Follow&nbsp;proper safety procedures for equipment repair and usage</li>
<li>Contact&nbsp;manufacturing representative for repair instructions or when requesting on-site assistance</li>
<li>Maintain&nbsp;proper flow of information regarding laser repair / progress status</li>
<li>Communicate&nbsp;with company Service Engineers, Operations Personnel, and Management in an effective and timely manner when needing assistance in obtaining parts or contacting for 3rd&nbsp;party repairs</li>
<li>Follow&nbsp;up with technicians following a repair to insure equipment functioned properly</li>
<li>Communicate&nbsp;with operations when equipment are operational/ready for service or out of service/inoperative/non-functioning</li>
<li>Complete timely and detailed Service Reporting, to include:
<ul>
<li>Maintenance &amp; PM documentation, to maintain an accurate account of each service event</li>
<li>Purchase order and parts requests and packing slip submittal</li>
</ul>
</li>
<li>Participate&nbsp;in continuing education of new equipment as necessary</li>
<li>Assist&nbsp;in training new service engineers on repair and operation of equipment</li>
</ul>
Qualifications 
Skills Required:
<ul>
<li>Must have good eye/hand coordination for complicated repair tasks</li>
<li>Must have basic knowledge of electronics and laser physics</li>
<li>Outstanding decision making and problem solving skills</li>
<li>Customer service focused</li>
<li>Proficient in Microsoft Office</li>
</ul>
Key Requirements:
<ul>
<li>Bachelor’s degree in electrical or biomedical engineering strongly preferred; Associate’s degree in electronics technology is a minimum requirement</li>
<li>Minimum 2 years’ experience in medical equipment service; candidates with&nbsp;surgical laser experience a plus</li>
<li>Flexible schedule with the ability to travel up to 50%&nbsp;</li>
<li>Valid driver’s license and acceptable driving record</li>
<li>Must be able to manipulate 50+ pounds of medical equipment</li>
</ul>
 Additional Information 
ForTec&nbsp;is an industry leader in improving patient health and healthcare by delivering innovative surgical laser technology to hospitals and healthcare professionals completely on demand. Present in more than 40 states, physicians enjoy the latest generation of surgical technologies from certified medical device manufacturers through our pay-per-use model.&nbsp;
All your information will be kept confidential according to EEO guidelines.
The Company is an equal opportunity employer. As such, we provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, citizenship, ethnicity, national origin, age, disability, pregnancy, genetic information, sexual orientation, status as a member of the United States armed forces, veteran status, or any other protected characteristic in accordance with applicable federal, state, and local laws.

Field Service Engineer

<h3>Job Description</h3>
Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.
Job Overview
GenScript is seeking a talented, detail oriented and self-driven individual to join the Engineering Equipment Department, contributing to the planning, design, construction, commissioning, validation, and engineering process systems development for our facilities in Piscataway, NJ. This position is valid for at least 2 years with opportunity to transition to facility manager after the construction projects are done.
Responsibilities
Project Planning and Execution: 
<ul>
<li>Develop comprehensive project plans ensuring projects proceed according to set objectives, including requirement gathering, feasibility analysis, risk assessment, and solution formulation.</li>
<li>Manage cost estimation for all project phases and create cost control plans.</li>
<li>Procurement and Contract Management.</li>
<li>Oversee bidding and procurement for project design, construction, and long-lead equipment.</li>
<li>Manage contract signing and execution with suppliers and contractors, ensuring compliance with terms, quality, and deadlines.</li>
</ul>
Project Management: 
<ul>
<li>Manage technical, quality, safety, and timeline aspects of projects, ensuring timely resolution of technical issues, compliance with quality standards, and implementation of safety measures.</li>
<li>Coordinate with construction firms, supervisory, and contracting units to manage internal and external project relationships.</li>
<li>Commissioning and Validation:</li>
<li>Organize factory acceptance tests, commissioning, and validation to ensure systems meet user requirements.</li>
</ul>
Project Completion: 
<ul>
<li>Lead the final inspection, handover, documentation review, and project settlement activities, ensuring successful project completion and handover.</li>
<li>Reporting and Improvement:</li>
<li>Regularly report project progress, compile project reports, analyze lessons learned, and suggest improvements.</li>
</ul>
Qualifications and Requirements
Education and Experience: 
<ul>
<li>Bachelor's degree or higher in Mechanical/Electrical, Chemical Engineering, Biomedical Engineering, or related fields.</li>
<li>5 years of experience in biopharmaceuticals with substantial project management and facility operations experience.</li>
<li>Hands on experience in managing construction, experience in executing projects from business requirement collection through to design, construction, commissioning, validation, and final settlement is preferred.</li>
</ul>
Skills: 
<ul>
<li>Strong management and reporting capabilities, clear management vision, able to handle high-pressure work environments.</li>
<li>Solid technical expertise combined with engineering knowledge.</li>
<li>Demonstrated skills in problem solving, root cause analysis with result driven thought process.</li>
</ul>
Additional Considerations: 
<ul>
<li>Proficient in project management software (e.g., Procore, Microsoft Project, Primavera P6).</li>
<li>Familiarity with construction estimating and scheduling tools.</li>
<li>Understanding of US building codes, zoning laws, safety regulations, and biopharmaceutical industry standards.</li>
</ul>
Benefits
<ul>
<li>Competitive salary with performance-based bonuses.</li>
<li>Comprehensive health, dental, and vision insurance.</li>
<li>401(k) retirement plan with company match.</li>
<li>Paid time off (PTO) and holidays.</li>
<li>Professional development and training opportunities.</li>
</ul>
#GS
#LI-EB1
GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.
Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Facilities/Construction Engineer

<h3>Job Description</h3>
Job Description
Our Company
Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry Instrumentation and the full range of reagents for immunohistochemistry and molecular lab testing. Biocare is the market leader in simultaneous Multiplex IHC tests which provide increased confidence at critical diagnostic decision points, impacting patient therapy while accelerating turnaround time.
 The company's customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare medical is headquartered and has manufacturing facilities in California and has a global distribution network.
Summary Competent and well-trained Field Service Engineer (FSE) to properly install, calibrate, diagnose problems, repair, and perform preventative maintenance on all assigned corporate and field based Biocare Medical and contracted competitive instruments &amp; equipment.
Territories Available
<ul>
<li>Upper Midwest - Illinois, Minnesota, Indiana, Michigan, Iowa, Missouri, Wisconsin</li>
<li>Western US</li>
<li>Eastern US</li>
</ul>
Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
<ul>
<li>Installation, calibration, diagnosis, repair, and preventative maintenance (PM) service of all assigned corporate and field based Biocare Medical and contracted competitive instruments &amp; equipment.</li>
<li>Provide technical support to clients, Biocare Medical Sales Team, Field Applications Specialists Team, and the Technical Support Department on the proper operation and maintenance of all assigned corporate and field based Biocare and contracted competitive equipment.</li>
<li>Serve as Biocare Medical's on-site client point-of-contact for instrument and instrument service issues.</li>
<li>Work closely, as needed, with Sales, Marketing, Engineering, QA/QC, and R&amp;D to address instrument concerns, determine corrective action, and ensure timely follow-up.</li>
<li>Participate in local, regional, and national histology/immunohistochemistry functions as needed.</li>
<li>Travel both domestically and internationally as required to ensure minimal instrument down time.</li>
<li>Work on complex assignments and show considerable judgement to ensure timely and successful repair of all corporate and field based Biocare Medical and contracted competitive equipment.</li>
<li>Other duties as assigned by management.</li>
</ul>
Competencies
<ul>
<li>Associate degree in Biomedical Equipment Technologies or very closely related field.</li>
<li>Two plus (2+) years Field Service Engineer (FSE) experience in the medical field or other very closely related instrument service field.</li>
<li>Electrical and mechanical troubleshooting competency. Robotics and Fluidics a plus.</li>
<li>Specialized equipment repair training, experience, and/or certification preferred. (BMET) (CBET)</li>
<li>Clear verbal and writing skills. Ability to prepare and present topics as required.</li>
<li>High level reading comprehension skills to interpret operating, maintenance, and troubleshooting instructions.</li>
<li>Advance computer skills for reporting and interacting with instrument computer hardware and software.</li>
<li>Attention to detail and good planning and organizational skills.</li>
<li>Ability to travel - this position requires 80% – 90% travel.</li>
</ul>
Expected Hours of Work
<ul>
<li>8 a.m. to 5 p.m. Monday - Friday and regularly requires long hours and occasional weekend work.</li>
</ul>
Compensation Range
<ul>
<li>$100,000 - $115,000 annual</li>
</ul>
Full-Time Positions Offer
<ul>
<li>Company Sponsored Health Insurance - medical, dental, vision,</li>
<li>Company Sponsored Life Insurance</li>
<li>Voluntary Benefits</li>
<li>Retirement plan - 401(k)</li>
<li>PTO</li>
<li>Paid Holidays</li>
</ul>
BioCare Medical values the diversity of individuals, ideas, and perspectives, and what they bring to the workplace. We know that our people represent the future of the company, so we only hire the best from around the world. Applications from all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or status as a Protected Veteran.
All inquiries strictly confidential.

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