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<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.
The position reports to the Head of Product Development and Manufacturing, and is responsible for meeting site production, safety, and quality requirements by developing and establishing automated systems for mRNA synthesis, quality control experiments, high throughput gene synthesis platform and other emerging molecular biology service lines at the Redmond site of the GenScript Innovation Center.
Responsibilities:
<ol>
<li>Independently manage or contribute to all laboratory automation projects including conception, design, development, acquisition, process implementation and execution of automation solutions for manufacturing</li>
<li>Define scope of project in consultation with supervisor and stakeholders. Individually or collaboratively through leadership of project team, define alternative solutions, and decision criteria used to evaluate alternatives.</li>
<li>Develop and optimize automation solutions for RNA synthesis by in vitro transcription and purification, and high throughput nucleic acid synthesis platforms. Script for automated platforms based on project needs.</li>
<li>Provide support for the DNA and RNA production line by leveraging automation tools to achieve revenue goals. Troubleshoot issues, if occur, with automation systems, propose effective solutions and coordinate system updates and enhancements to optimize performance.</li>
<li>Oversee preventative maintenance and calibration of automated system instruments, ensuring optimal performance and reliability. Collaborate with the equipment engineering team, internal stakeholders including QA team, production team and external vendors to provide technical input, review and approve testing documents and protocols of automation systems as needed.</li>
<li>Acquire new technologies to develop, optimize and improve existing high throughput laboratory automation systems.</li>
<li>Provide day-to-day maintenance and production support for the manufacturing equipment and staff.</li>
</ol>
Qualifications
<ol>
<li>BS in Engineering Discipline or Biology/ Biochemistry/ Molecular Biology/ Biomedical Instrumentation/ related subjects with 2+ years of automation experience in manufacturing</li>
<li>Proven track of workflow design and process optimization with automation</li>
<li>Experience in transforming bench work process to automation solutions</li>
<li>Knowledge of commercial automated liquid handlers, experience in handling/maintaining automated liquid handlers, e.g., Tecan, Beckman, PerkinElmer, etc.</li>
<li>Basic understanding of hands-on molecular biology experiments is required</li>
<li>Knowledge of automated production line is a plus</li>
<li>Ability to effectively interact with individuals at all levels and good organizational and project management skills.</li>
<li>Patient, attend to details and is able to follow SOPs</li>
<li>Flexible to work in non-standard work hours in the case of emergency situations</li>
</ol>
Benefit:
<ul>
<li>Medical Insurance/ Vision Insurance/ Dental Insurance</li>
<li>401(k) &amp; Retirement Savings Plan (RSP)</li>
<li>Short Term Disability Insurance</li>
<li>New Child Leave</li>
<li>Paid Time Off</li>
<li>Paid Company Holidays per year</li>
<li>Paid Sick Days (earned based on hours worked)</li>
<li>Compassionate Leave</li>
<li>Jury Duty Leave</li>
<li>Float day</li>
<li>Personal days</li>
</ul>
Perks: 
<ul>
<li>Free colleague meals during shift</li>
<li>Onsite massage Charis</li>
<li>Onsite gyms</li>
</ul>
Compensation: Salary range: $85,000 – $130,000, depending on experience and qualifications.
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.

Automation Engineer

<h3>Job Description</h3>
Job Description
About Spectrum Vascular
Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. 
Role Description:
The Quality Engineer is responsible for providing hands-on support to assure the successful transfer of acquired technology to a contract manufacturing partner on schedule. This position will monitor, maintain, and/or improve the quality and performance of the Spectrum Vascular catheter product portfolio through technical evaluations, maintenance of design history files, and quality support to address user and/or business needs. 
Key Responsibilities:
<ul>
<li> Execute activities necessary to support the vascular access business, specifically the PICC and Mid-line catheter portfolio.</li>
<li> Monitors, maintains, and/or improves the quality and performance of the portfolio through technical evaluations, design history file maintenance, and design improvement implementation to address user and/or business needs.</li>
<li> Perform technical evaluations related to supplier and manufacturing changes to existing products.</li>
<li> Perform design change assessments to determine impact of changes to commercial products.</li>
<li> Support new indications, regulations, and marketed regions associated with existing commercial products.</li>
<li> Maintain Risk Management Files for existing products based on post market surveillance.</li>
<li> Interfaces with external suppliers and internal project teams to ensure the quality of Spectrum Vascular products. </li>
<li> Review test protocols and reports to support development and transfer of projects. </li>
<li> Ensure all activities are executed in alignment with design controls, with the proper documentation for traceability. Support Regulatory filing activities (per 21 CFR 820.30, 21 CFR part 4, ISO 13485), and work closely with team to establish and maintain design control procedures.</li>
<li> Partner with functional areas to develop appropriate prioritization plans and appropriately escalate changes in resource demand, risks, gaps, or challenges.</li>
<li> Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program.</li>
<li> Effectively manage multiple projects and responsibilities.</li>
</ul>
Role Requirements:
<ul>
<li> Bachelor's degree in mechanical or biomedical engineering preferred.</li>
<li> Three years-plus of relevant medical device industry experience in quality engineering and/or manufacturing operations.</li>
<li> Knowledge and understanding of molding and extrusion operations, as well as assembly, labeling, and packaging.</li>
<li> Good understanding of FDA regulations, QMS, GMP and ISO standards.</li>
<li> Experience managing diverse project activities with contract CMO facilities, and in particular managing and communicating quality requirements between vendors.</li>
<li> Strong computer skills including proficiency in Excel, Word, SolidWorks, eQMS, and statistical methods.</li>
<li> Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results.</li>
<li> Natural entrepreneurial spirit with unrelenting dedication to delivering results.</li>
<li> Desire to work in a fast-paced, innovative environment.</li>
<li> Natural collaborator who enjoys working on a cross-functional team.</li>
</ul>
Work Environment:
<ul>
<li> Remote-based</li>
<li> Dynamic, interactive, fast-paced, and entrepreneurial environment</li>
<li> Travel – up to 35%, additional may be required during execution of validation activities</li>
</ul>
Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law. 
ime.

Quality Engineer

<h3>Job Description</h3>
Job Description
 
See yourself as a MoFe Engineer at Sightpath Medical!!
In addition to learning the latest innovations in the ophthalmic industry, Sightpath Medical offers a challenging and rewarding environment where you'll work with smart, fun and energetic people.
 &nbsp;• Sightpath Medical is the premier cataract and LASIK mobile services provider in the U.S. &nbsp;• We provide an independent working atmosphere &nbsp;• We provide on the job training to help you become an expert in our area of expertise &nbsp;• Salary position with quarterly bonus eligibility &nbsp;• 401(k) plan &nbsp;• Medical Benefits including medical, dental, vision, health savings account, short term disability, long term disability &nbsp;• Health and Wellness Program &nbsp; &nbsp;Responsibilities: &nbsp;• Requires the ability to install/de-install and operate transportable lasers and related equipment on one business unit at&nbsp;&nbsp;&nbsp; customer sites. &nbsp;• Responsible for calibration and programming of equipment for surgeon's approval prior to surgery being performed. &nbsp;• Responsible for the operation of both lasers when they are both required. &nbsp;• Provide routine preventative maintenance and repairs on the laser systems to maximize usage and minimize downtime. &nbsp;• Ability to troubleshoot, remove and replace components of the laser and calibrate to vendor specifications. &nbsp;• Responsible for maintaining all company assets in good working order. &nbsp;• Adherence to company standard operating procedures that meet/exceed standard of care. &nbsp;• Ability to complete Annual and Semi-Annual Preventative Maintenance checks and services on all assigned equipment. Successfully completes all PM paperwork during &nbsp;and at the end of PM. &nbsp;• Understands and adheres to proper sterile technique. &nbsp;• Other duties as required &nbsp; &nbsp;Qualifications: &nbsp;• Degree in Laser Electro-optics, Biomedical Electronics, Electronics or military training equivalent. &nbsp;• Proficiency with basic electronics and associated test equipment. &nbsp;• Able to work a varied work schedule and travel. &nbsp;• Able to work in a team environment. &nbsp;• Valid Driver's License &nbsp;• Ability to pass company administered road test. &nbsp;• Ability to occasionally lift 50 lbs. &nbsp;• Ability to stand for extended periods of time. &nbsp;• Able to work a varied work schedule and travel. &nbsp;• Great customer service skills.
 
 
PM25
 
Compensation details: 65000-75000 Yearly Salary
 
PI56a4b0128b7c-25405-38089401

MoFe Engineer I

<h3>Job Description</h3>
Job DescriptionJob Title: Manufacturing Engineer Company: VistaApex Solutions Location: Racine, Wisconsin (Corporate Headquarters) Reports to: Director of Operations About VistaApex Solutions VistaApex Solutions is a purpose-driven, clinician-focused healthcare platform bringing together leading dental brands, including Vista Apex, PerioProtect, and PerioSciences. Our mission is to develop meaningful products that enhance clinicians’ treatment options and improve patient outcomes. With a value-added approach across R&amp;D, operations, and customer experience.&nbsp; We empower clinicians to deliver confident, consistent, and elevated care. At our core, we operate through five foundational pillars— Product Development + Clinician Involvement, Treatment Refinement + Simplified Workflow, Expanding Innovations + Trusted Partnerships, Inspired Foresight and Quality Assured + Personal Connections —guiding our approach to innovation, collaboration, and long-term partnership. Position Overview The Manufacturing Engineer plays a critical role in driving continuous improvement across VistaApex’s operations. This position is responsible for identifying and implementing opportunities to enhance product value, reduce costs, and improve overall performance through systematic analysis and sound engineering practices. A key responsibility of this role is to strengthen the vendor base for VistaApex. This includes identifying and onboarding new suppliers, either domestically within the United States or in international regions with favorable tariff structures. The Manufacturing Engineer will also support the integration and commissioning of new equipment at the VistaApex facility to support production and operational efficiency. This role collaborates closely with cross-functional teams, including design, sourcing, and supply chain, to ensure alignment of manufacturing initiatives with overall business objectives. Key Functions
<ul>
<li>Determines company product manufacturing needs and provides technical resources to accomplish a smooth transition within the manufacturing environment. Handling the handoff from project design to manufacturability and automating</li>
<li>Conduct thorough value analysis and engineering assessments on existing and new products to identify cost-saving opportunities and performance improvements.</li>
<li>Collaborate with design and manufacturing teams to implement effective design changes and material substitutions.</li>
<li>Lead workshops and brainstorming sessions to generate innovative ideas for product enhancements.</li>
<li>Analyze product lifecycle costs and provide recommendations to optimize value throughout the product development process.</li>
<li>Monitor and evaluate the effectiveness of implemented changes, providing feedback for continuous improvement.</li>
<li>Stay updated on industry trends and best practices in value engineering and product development.</li>
<li>Conduct comprehensive value analysis and engineering assessments on existing and new products to identify significant cost-saving opportunities and performance enhancements.</li>
<li>Lead the qualification and onboarding process for new vendors, ensuring alignment with company standards and strategic goals.</li>
<li>Solves problems associated with manufacturing fallout and system bottlenecks</li>
<li>Plans for the arrangement of machines within the plant facilities to ensure the most efficient production processing layout</li>
<li>Installation of automated equipment for tip manufacturing and kitting improvements</li>
<li>Plant Layout analysis while new business is onboarded</li>
<li>Open molds or identify new pieces of equipment to bring production of appropriate SKUs in house. Assist with the set-up of equipment and training personnel. </li>
<li>Identify and onboard new vendors in the United States and countries with lower tariffs to the United States to mitigate the current supply chain exposure.</li>
<li>Analyze dual source and dual path options for highest spend SKUs, to determine if it makes sense to bring production in house and to have multiple options in different countries.</li>
<li>Drive cost savings or cost avoidance initiatives for each SKU.</li>
<li>Push internal documentation through Vista Apex Change Control Process to qualify and approve new vendors.</li>
<li>Develop drawings, Receiving Inspection Reports, and other documentation needed for change management.</li>
<li>Other duties as assigned</li>
</ul>
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required. Job Requirements
<ul>
<li>Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related field) or equivalent experience; Master’s degree is a plus.</li>
<li>Proven experience in manufacturing engineering, preferably in a medical manufacturing environment.</li>
<li>Experience with product development and strong project management skills, including the ability to manage multiple projects simultaneously.</li>
<li>Proficient in Microsoft Office, particularly Excel; experience with Microsoft Project is helpful.</li>
<li>Proficient in engineering tools and software, such as CAD and other relevant technical applications.</li>
<li>Strong analytical and problem-solving skills, with a focus on cost reduction and performance improvement.</li>
<li>Excellent communication and interpersonal skills, with the ability to work collaboratively across teams.</li>
<li>Familiarity with lean manufacturing principles and continuous improvement methodologies is a plus.</li>
<li>Experience onboarding new vendors in previous roles is a plus.</li>
</ul>
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
<ul>
<li>While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle, or touch objects; and talk or hear. The employee is occasionally required to stand, walk, climb or balance, and taste or smell. The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.</li>
</ul>
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
<ul>
<li>The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.</li>
<li>The position is an office-based position.</li>
<li>Fast-paced, dynamic environment requiring adaptability and proactive communication.</li>
</ul>
Benefits We believe in supporting our employees both inside and outside of work. Here’s what you can expect when you join our team:
<ul>
<li>Comprehensive Health Coverage: Medical, dental, and vision insurance for you and your dependents.</li>
<li>Time Off: Generous PTO policy and paid holidays</li>
<li>Retirement Plans: 401(k) with company matching to help you plan for the future.</li>
<li>Wellness Support: Mental health resources and wellness programs.</li>
<li>Team Connection: Regular team events, retreats, and gatherings to build community.</li>
</ul>
 &nbsp;
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Manufacturing Engineer

<h3>Job Description</h3>
Job DescriptionDescription:
Our client, an industry leader in medical device manufacturing, has an excellent opportunity for a Quality Engineer to work on a 6+month contract opportunity. Work will be on-site in San Diego, CA. The Quality Engineer will lead Test Method Validation (TMV) activities including protocol development, execution, and reporting..
 
Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
 
Rate: $50 - $55 / hr. w2
 Responsibilities:
· Develop and validate test methods to ensure compliance with internal and external standards. 
· Conduct Measurement System Analysis (MSA) including Gage Repeatability and Reproducibility (GR&amp;R) studies to assess and improve measurement reliability. 
· Collaborate cross-functionally with R&amp;D, Quality, and Manufacturing teams to ensure test methods meet product and business requirements. 
· Analyze data using statistical tools to evaluate method performance and identify areas for improvement. 
· Author and maintain validation documentation including protocols, reports, and risk assessments. 
· Flexibility to work off shifts and overtime based on equipment availability.
 Experience Requirements:
· Proficiency in statistical analysis software (e.g. JMP, Minitab) 
· Experience authoring and maintaining validation documents
· Statistical Analysis in MSA and Gauge R&amp;R
· Experience with project management tools such as JIRA, Confluence, Smartsheet
· Strong problem solving skills when validating both destructive and non-destructive test methods. 
· Highly familiar with vision-based metrology equipment 
· Have a preventative mindset through anticipating potential problems. 
· Excellent written and oral communication skills. 
· Flexibility to occasionally work 2nd shift based on equipment availability.
 Education Requirements:
· Bachelor’s degree in Engineering required, with a preference for Mechanical, Chemical, or Biomedical Engineering.
 
Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range. W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality. Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact <a href="mailto:InfoSec@eliassen.com" target="_blank">InfoSec@eliassen.com</a>.
About Eliassen Group:

Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk &amp; compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

<h3>Job Description</h3>
Job DescriptionDEKA R&amp;D has an immediate opening for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment.&nbsp; The position reports to the Product Complaints Manager.&nbsp; This is a high visibility role with a significant direct impact in the Quality Management System. How you will make an impact:
<ul>
<li>Responsible for reviewing complaints related to potential medical device issues.&nbsp;</li>
<li>Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge.</li>
<li>Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements.</li>
<li>Identify and make sound decisions regarding medical device reporting to regulatory agencies.</li>
<li>Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.</li>
<li>Participate in audits and CAPA investigations as they relate to complaint handling.</li>
<li>Work with the forensic investigation team to align product investigations related to complaints.</li>
<li>Generate reports to identify areas of process improvement.</li>
<li>Develop product training aids.</li>
<li>Contribute independently while also collaborating with other team members and departments needing product complaint information.</li>
<li>Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.</li>
<li>Serve as a subject matter expert on complaint handling.</li>
<li>Perform other related duties as assigned under management supervision.</li>
</ul>
Skills needed to be successful:
<ul>
<li>4-year engineering degree, preferably in biomedical engineering; OR 2-year degree and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis.</li>
<li>Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.</li>
<li>Experience with SalesForce is preferred.</li>
<li>Strong motivation to see individual tasks through to completion, and to help as needed to achieve team goals.</li>
<li>Exceptional time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures.</li>
<li>Good problem-solving and proficient computer skills are required.</li>
<li>Solid written/verbal communication and organizational skills, as well as attention to detail.</li>
<li>Sound technical writing skills.</li>
<li>Ability to work well independently and on cross-functional teams in a fast-paced, changing environment.</li>
</ul>
About DEKA: One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research &amp; Development, where we are taking the same innovation and cutting-edge technology into the modern age. Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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Product Complaints Engineer

<h3>Job Description</h3>
Job Description
AUTOMATION ENGINEER
 
POSITION SUMMARY: 
The Automation Engineer within the Production Engineering Group contributes to the implementation of automation systems and workflows to support the processing of samples in a clinical diagnostics laboratory environment. This individual collaborates with teams to implement and support solutions designed to optimize the performance and increase the efficiencies of the laboratory processes.
PRIMARY RESPONSIBILITIES:
<ul>
<li>Program and deploy liquid handling robots and work cells</li>
<li>Support production through troubleshooting down liquid handling robots and work cells</li>
<li>Build rapport with end-users, and engineering colleagues</li>
<li>Deploy, optimize, support and test the automation systems and related software tools.</li>
<li>Promptly complete documentation utilizing good documentation practices.</li>
<li>Prepare User Requirement and Testing Procedure, Standard Operating Procedures, and related documentations</li>
<li>Perform the functional testing and qualification</li>
<li>Additional responsibilities as needed</li>
</ul>
QUALIFICATIONS:
<ul>
<li>BS degree in Biomedical engineering, closely related scientific field, or equivalent</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>
The 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.San Carlos, CA $112,000—$140,000 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

<h3>Job Description</h3>
Job Title: Product Development Engineer
12 month contract 
On-site in Cary, IL 
Must be able to work on a W2 
 
Job Summary
The Product Development Engineer will be responsible for designing, validating, and bringing new medical device products to market. This role includes developing product requirements, creating CAD/CAE models, testing and integrating components, and evaluating overall product performance, cost, reliability, and safety. The engineer will collaborate closely with manufacturing partners, contract manufacturers, and product specialists to optimize designs for manufacturability. This is an independent contributor position requiring strong technical expertise, attention to detail, and the ability to work with minimal supervision.
 
Job Responsibilities
<ul>
<li>Design, develop, and validate new medical device products from concept through market launch.</li>
<li>Specify functional requirements, product specifications, and process validation plans.</li>
<li>Plan and execute product testing to assess reliability, safety, and compliance with standards.</li>
<li>Develop and execute product validation protocols, ensuring designs meet intended use and regulatory requirements.</li>
<li>Apply design-for-manufacturability (DFM) principles to ensure efficient, cost-effective production.</li>
<li>Create and review material part specifications and bills of materials.</li>
<li>Collaborate with internal teams, contract manufacturers, and product specialists to ensure smooth transfer to manufacturing.</li>
<li>Utilize CAD (Computer-Aided Design) and CAE (Computer-Aided Engineering) systems to model designs and generate detailed engineering drawings.</li>
</ul>
 
Job Qualifications
<ul>
<li>Bachelor’s degree in Engineering (Mechanical, Biomedical, or related discipline) or equivalent practical experience.</li>
<li>2–8 years of engineering experience in product development, preferably in the medical device industry.</li>
<li>Proficiency with CAD/CAE tools for design and modeling.</li>
<li>Strong knowledge of product testing methods, validation processes, and design-for-manufacturability principles.</li>
<li>Familiarity with regulatory and quality standards for medical devices (ISO 13485, FDA, etc.) preferred.</li>
<li>Ability to work independently, manage multiple projects, and collaborate across functions.</li>
</ul>

Product Development Engineer

<h3>Job Description</h3>
Job Description
IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, and the European Medical Device Regulation (MDR). Based on the position, experience in a regulated environment and the extent of working knowledge of appropriate regulations may vary. 
PURPOSE OF JOB:
The Quality Assurance (QA) department is committed to ensuring that all products are safe, reliable, and effective, consistently exceeding the expectations of patients, physicians, and healthcare providers. QA plays a critical role in maintaining product and process quality throughout the commercial production of Iridex’s portfolio, including laser consoles, delivery devices, and accessories.
In this role, the Quality Engineer will assist with the identification and resolution of product and process quality issues. Responsibilities include supporting root cause investigations, tracking corrective actions, evaluating nonconforming materials, and helping maintain compliance with FDA and ISO 13485 requirements. The position offers hands-on experience in a regulated manufacturing environment with exposure to electromechanical and software-integrated medical devices.
MAJOR DUTIES AND RESPONSIBILITIES:
<ul>
<li>Support investigations for product quality issues across mechanical, electrical, and software components.</li>
<li>Assist in root cause analysis and contribute to Corrective and Preventive Action (CAPA) activities.</li>
<li>Manage the Nonconforming Material (NC) process end-to-end—from identification and evaluation to coordination of the Material Review Board (MRB) for timely and effective disposition of nonconforming product.</li>
<li>Assist in supplier quality management activities, including performance monitoring, documentation maintenance, and follow-up on Supplier Corrective Actions (SCARs) to ensure root cause resolution and sustainable improvements.</li>
<li>Collaborate with Manufacturing and Engineering teams to evaluate process improvements and product quality concerns.</li>
<li>Support incoming inspection process, verification of components, and evaluation of test data.</li>
<li>Review Engineering Change Orders (ECOs) for quality impact under supervision.</li>
<li>Contribute to risk management documentation (e.g., FMEA) as part of design and process evaluations.</li>
<li>Assist in managing the calibration program for measurement equipment and support investigations of out-of-tolerance (OOT) tools.</li>
<li>Assist in the documentation of complaint investigations and return analysis reports.</li>
<li>Participate in internal audits, supplier evaluations, and quality improvement projects.</li>
<li>Maintain detailed records, forms, and reports in accordance with QMS and regulatory requirements.</li>
</ul>
JOB SKILLS:
<ul>
<li>Solid understanding of quality engineering principles (e.g., CAPA, NCRs, risk analysis).</li>
<li>Familiarity with FDA 21 CFR 820, ISO 13485, and ISO 14971 requirements.</li>
<li>Familiarity with medical device standards such as IEC 60601 is advantageous.</li>
<li>Ability to read and interpret engineering drawings and specifications.</li>
<li>Working knowledge of basic inspection tools and techniques.</li>
<li>Strong analytical and problem-solving skills, including root cause analysis techniques.</li>
<li>Effective communication skills and ability to work in cross-functional teams.</li>
<li>Attention to detail, organizational skills, and the ability to manage multiple priorities.</li>
<li>Detail-oriented with a commitment to quality and continuous learning.</li>
<li>Basic understanding of statistical analysis and sampling methods is a plus.</li>
</ul>
QUALIFICATIONS:
<ul>
<li>Bachelor’s degree in Biomedical, Mechanical, Industrial, or related engineering field.</li>
<li>2 to 5 years of experience in a Quality or Manufacturing Engineering role, preferably in a medical device or regulated industry.</li>
<li>Experience with CAPA, and nonconformance systems preferred.</li>
<li>Working knowledge of risk management tools (FMEA) and quality planning.</li>
<li>Certification such as ASQ Certified Quality Engineer (CQE) is a plus.</li>
<li>Advanced problem-solving skills including troubleshooting and root cause analysis</li>
<li>Familiarity with sterilization validation, environmental monitoring, and cleanroom protocols is desirable.</li>
<li>Effective written and verbal communication skills in English.</li>
<li>Basic knowledge and understanding of Quality Management System regulations including but not limited to ISO 13485 and 21CFR820. </li>
</ul>
ADDITIONAL INFORMATION:
<ul>
<li>Department: QA</li>
<li>Reports To: Sr. Manager, Quality Assurance</li>
<li>FLSA Status: Exempt</li>
<li>Base Salary: $80,000 - $118,000 DoE</li>
<li>Travel: 10% </li>
<li>Work Location: This job will be primarily onsite; the percentage of supplier-visit work will be defined by the management</li>
</ul>

<h3>Job Description</h3>
Job Description
Job Title: Packaging Engineer
Duration: 12+ Months
Location: Round Lake, IL 60073
Job Description:
This position is a contract Packaging Engineering position within our pharmaceutical segment R&amp;D group.
With some supervision, performs sustaining engineering activities on current product packaging and packaging processes with priorities based on quality and compliance, continuity of supply, and cost savings initiatives.
When applicable, will support new product development teams by acting as an extended team member to provide the design, development and verification testing of new product packaging and assist the manufacturing plants in qualification of new packaging processes.
This position applies a solid understanding of theories/practices utilized in the field of packaging.
The position will include exposure to several types of packaging materials and processes including flexible and rigid films, HDPE and foil pouches, corrugated design and protective packaging, thermoforming, flow-wrap, form/fill/seal, printing technologies and other related packaging processes.
The position may require travel to the manufacturing plants and packaging suppliers.
Essential Duties and Responsibilities:
Lead and/or contribute to the planning and execution of packaging projects for a variety of project types including Quality/CAPA, Regulatory Compliance, Supplier Notices of Change, Cost Savings, and New Product Introductions at various domestic and international manufacturing facilities.
Manage projects with moderate complexity and scope and be required to effectively manage multiple projects with minimal assistance and supervision.
May work on a large-scale program or several smaller projects.
Develop protocols for testing and engage in Change Control activities interfacing with multiple functional groups, including manufacturing plants and suppliers in a team environment to execute packaging changes.
Approve new packaging materials and systems, studying and recommending techniques to improve and/or cost reduce existing products/processes, investigating new sources for packaging materials.
Create packaging material specifications, associated drawings, and packaging procedural specifications to provide the required technical information necessary to support the product/packaging configuration.
Plans, schedules, and collaborates with cross-functional team supporting packaging projects to achieved project objectives and milestones.
Expected to utilize their experience to generate cost savings ideas by recommending new materials or design modifications and resolve packaging issues by using critical thinking skills and DMAIC techniques to solve complex problems.
Perform financial planning and assists in the analysis to justify project approval.
Required Education &amp; Qualifications:
B.S. in Packaging or relevant Engineering degree (e.g. Mechanical, Chemical, Biomedical) with a minimum of 5 years of experience.
Must have experience or advanced training and demonstrate proficiency in packaging materials and processes, problem analysis and resolution, statistical methods, and design of experiments.
Proficient in applicable change control and development methodology and processes required to execute packaging projects.
Successful track record of managing packaging projects possessing a sense of urgency and commitment to meet project milestones to ensure manufacturing plants and R&amp;D teams achieve targeted goals.
Cross-functional team experience, including technical and non-technical work.
The ability to deal with ambiguity and effective use of creative problem-solving skills.
Embrace Lean Principals and utilize concepts such as standard work to drive continuous improvement.
Ability to organize and present technical and project management overviews with minimal assistance.
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

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