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<h3>Job Description</h3>
Job DescriptionSage Product Development, Inc. Senior Electromechanical 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 and electromechanical 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. Provide input on electromechanical considerations across multiple projects. Lead and participate in concept generation activities, including brainstorming sessions. Refine, rate, rank and/or otherwise assess concepts.</li>
<li>Design and prototype electromechanical systems. Program prototype microcontrollers. Utilize SolidWorks to develop detailed 3-D CAD models and drawings, including component, subassembly, and top-level drawings.</li>
<li>Research and select electrical and electromechanical components such as sensors, actuators, controllers, connectors and boards. 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>Collaborate with consultants and vendors to guide custom circuit board and software design. 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. Build and debug electromechanical assemblies including soldering, wiring, board assembly and mechanical assembly.</li>
<li>Conduct bench and/or animal feasibility studies.</li>
<li>Conduct product verification and validation testing to demonstrate product safety and efficacy. Manage software validation activities. 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. Manage IEC 60601, IEC 61010, EMC and/or EMI testing at outside vendors and troubleshoot failures.</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>
&nbsp;PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES: 
<ul>
<li>Bachelor's degree in Mechanical, Electrical or Biomedical Engineering or equivalent 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>Experience in electrical and/or electromechanical medical device design and development is required.</li>
<li>Working knowledge of common electromechanical components such as sensors, actuators, controllers and connectors.&nbsp;</li>
<li>Programming of Arduino or similar controllers for prototyping. Programming for final devices and/or multiple programming languages is preferred.&nbsp;</li>
<li>Familiarity with circuit board design.&nbsp; Capability to design custom circuit boards or software independently a plus.</li>
<li>Proficiency with soldering, wiring systems and electrical assembly.</li>
<li>SolidWorks 3D CAD proficiency is preferred.</li>
<li>Experience with software validation is preferred.</li>
<li>Knowledge of probability and statistics is preferred.</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>Experience with IEC 60601, IEC 61010, EMC and/or EMI testing and failure mitigation.</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>
</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>
&nbsp;TRAINING: 
<ul>
<li>Training requirements are defined in the Sage Training Log.</li>
</ul>

Sr. Biomedical Engineer (electrical focus/IEC 60601, IEC 61010)

<h3>Job Description</h3>
Job DescriptionSalary: $32.00 to $40.00 DOE 
A biomedical engineer or biomedical equipment technician (BMET) is needed to support a critical access hospital.
A Level II BMET. Performs skilled work on preventive maintenance, repair, safety testing, and recording functional test data. Usually has less than four years of BMET or related experience.
JOB ENVIRONMENT:
Position hours are primarily weekdays between the hours of 7:30am to 4:30pm. Call may be required after the normal workday is finished, during the week, and on weekends. The position may require travel to Technical Life Care customer remote clinic locations.
PRIMARY RESPONSIBILITIES:
Primary Responsibilities under the direction of the TLC Management or Level IV BMET include the following, however, this list is not all-inclusive and other duties and responsibilities may be assigned 
Essential Job Functions:
<ul>
<li>Perform a variety of routine tasks associated with service and calibration of a diverse range of medical instrumentation.</li>
<li>Assemble, repair and maintain medical devices according to recommended specifications.</li>
<li>Perform electrical safety tests on medical devices using specialized test equipment.</li>
<li>Maintain a preventive maintenance program.</li>
<li>Responds to service requests from hospital staff in a timely manner.</li>
<li>Keeps calibration/repair records as work orders in the equipment management database.</li>
<li>Adheres to all regulatory requirements of pertinent regulatory agencies such as Joint Commission, OSHA, AAMI, and NFPA 99.</li>
<li>Assists in maintaining a safe and clean work environment.</li>
<li>Serves as a positive role model to others in service excellence and communication.</li>
</ul>
PERSONAL AND PROFESSIONAL GROWTH:
Essential Job Functions:
<ul>
<li>Demonstrates the role in a professional manner.</li>
<li>Assumes accountability for his/her position and equipment, e.g. extends self when unusual need arises.</li>
<li>Attends scheduled department meetings and promotes Technical Life Care when appropriate.</li>
<li>Accepts constructive criticism regarding own performance and strives to make improvements.</li>
<li>Exhibits courtesy, compassion and respect to patients, families, visitors, physicians, and co-workers.</li>
<li>Maintains competencies through regular participation in service education programs.</li>
<li>Maintain patient confidentiality and health record security in accordance with regulatory standards including, but not limited to HIPAA.</li>
</ul>
MINIMUM QUALIFICATIONS:
<ul>
<li>Completion of a 2-year BMET program leading to an Associate of Science (AS) from an accredited institution.</li>
<li>Additional qualifying experience may be substituted for the required education on a year to year basis and completion of an advanced military electronics school may be substituted for the two years of education.</li>
<li>Effective oral and written communication skills.</li>
</ul>
Strong critical thinking skills.

Biomedical Equipment Technician Mankato, MN

<h3>Job Description</h3>
Job Description
Job Summary:
The Bio-medical Support Specialist provides clinical and administrative support to staff, patients, and administrators for all matters concerning the facility-wide lifecycle management of medical equipment. This role requires the application of engineering and mechanical concepts to provide lifecycle management and technical support of equipment used in medical practice, aiming to improve care provided by clinical staff.
Essential Functions: 
• Provide clinical and administrative support for the lifecycle management of medical equipment.
• Apply engineering and mechanical concepts to manage and support medical equipment.
• Coordinate with other facility support departments, including Facilities Management Service, Office of Information Technology, Patient Safety, Sterile Processing Service, Logistics, Contracting, Informatics, and Environmental Management Service.
• Perform tasks such as incoming inspections, regular and unscheduled maintenance, and planning for end-of-life replacement in conjunction with clinical services.
• Utilize common test equipment, including patient simulators, pulse generators, network analyzers, test phantoms, electrical safety analyzers, oscilloscopes, and multimeters.
• Maintain functional knowledge of relevant safety codes and standards of regulatory bodies, including The Joint Commission, National Fire Protection Association, Food and Drug Administration, and Nuclear Regulatory Commission.
• Document all work performed in the computerized maintenance management system in accordance with regulatory body requirements and GPTLHB/OHC policies. 
Requirements:
• Participates in Core Connections training and applies GPTLHB Core Connections concepts and practices in their work.
• Familiarity and/or experience working with American Indian populations and respect for and knowledge of traditional, cultural, and spiritual practices of diverse American Indian communities, as well as an ability to work with other culturally and ethnically diverse populations.
• Proficiency with computer programs (Word, Excel, PowerPoint) and other Internet technologies.
• Valid driver’s license must be kept current, and certificates, credentials or licenses must be kept current and consistent with regulations required by applicable federal, state and/or grant regulations as applies to position. 
• Work in a cooperative and professional manner with OHC and GPTLHB staff. 
• Treat Great Plains tribes and collaborators with dignity and respect. 
• Utilize effective verbal and written communication skills. 
• Advance personal educational development by attending training sessions and seminars as appropriate. 
• Exemplify excellent customer service with tribal stakeholders, health board colleagues, program partners, service recipients, visitors and guests. 
• Foster a work environment of wellness, courtesy, friendliness, helpfulness and respect. 
• Consistently demonstrate respect for and acceptance of differing capabilities, cultures, gender, age, sexual orientation and/or personalities. 
• Maintain and ensure organizational privacy and confidentiality. 
• Promote an alcohol, tobacco and drug-free lifestyle. 
Direct Reports:
None
MINIMUM EDUCATION &amp; EXPERIENCE REQUIREMENTS LEVEL I:
Completion of a formal training program or an associate’s degree and one (1) year of relevant experience; or a high school diploma or GED and three (3) years of relevant experience.
Must be familiar with standards and codes which apply to the operation of hospitals and clinics, including Det Norske Veritas (DNV}, The Joint Commission (TJC}, Accreditation Association for Ambulatory Health Care (AAAHC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA) and professional organizations such as the Association for the Advancement of Medical Instrumentation (AAMI) and others. 
Certification as a Biomedical Engineering Technician (CBET), or other certification provided through the AAMI Credentials Institute; Certified Clinical Engineer (CCE) through the ACCE, or equivalent is desirable and preferred. Certificates of training, or professional certificates in Information Technologies related fields, such as from CompTIA, Cisco, or Microsoft is desirable. 
MINIMUM EDUCATION &amp; EXPERIENCE REQUIREMENTS LEVEL II:
Completion of a formal training program or an associate’s degree and one (1) year of relevant experience; or a high school diploma or GED and three (3) years of relevant experience; Or three (3) years of service at Great Plains Tribal Leaders Health Board/Oyate Health Center at Level I; Or demonstrated proficiency at Biomedical Equipment Support Specialist Level I. 
Must be familiar with standards and codes which apply to the operation of hospitals and clinics, including Joint Commission on the Accreditation of Healthcare Facilities (JCAHO), National Fire Protection Association (NFPA), Food and Drug Administration (FDA) and professional organizations such as the Association for the Advancement of Medical Instrumentation (AAMI) and others. 
Certification as a Biomedical Engineering Technician through the ICC (AAMI/ACCE), the Veterans Administration or other nationally recognized organizations is desirable. Certificates of training, or professional certificates in Information Technologies related fields, such as from CompTIA, Cisco, or Microsoft is desirable. 
MINIMUM EDUCATION &amp; EXPERIENCE REQUIREMENTS LEVEL III:
Completion of a formal training program or an associate’s degree and one (1) year of relevant experience; or a high school diploma or GED and three (3) years of relevant experience. Or five (5) years of service at Great Plains Tribal Leaders Health Board/Oyate Health Center at Level I; Or demonstrated proficiency at Biomedical Equipment Support Specialist Level II. 
Knowledge of the functions, capabilities, limitation, operations, and design of a variety of patient care equipment and measurements is necessary. 
Must be familiar with standards and codes which apply to the operation of hospitals and clinics, including Joint Commission on the Accreditation of Healthcare Facilities (JCAHO), National Fire Protection Association (NFPA), Food and Drug Administration (FDA) and professional organizations such as the Association for the Advancement of Medical Instrumentation (AAMI) and others. Certification as a Biomedical Engineering Technician through the ICC (AAMI/ACCE), the Veterans Administration or other nationally recognized organizations is desirable. Certificates of training, or professional certificates in Information Technologies related fields, such as from CompTIA, Cisco, or Microsoft is desirable. 
The GPTLHB is a tribal organization that follows tribal preference laws. Our policy is to give preference to qualified Indian/Tribal candidates over qualified non-native candidates in hiring decisions if all other qualifications are equal. 
Employment is contingent upon the outcome of all required criminal background checks. 
Employee Health Requirements:
Compliance with our Employee Health Procedure is a condition of employment. You are required to agree that you will comply with all job-related employee health screening and immunizations prior to your first day of employment. Jobs require that you have documentation that you have completed the following immunizations prior to your first day of employment: MMR (Measles, Mumps and Rubella, Varicella (Chicken Pox), Hepatitis B, Influenza, T-dap (Tetanus - Diphtheria - Pertussis), and COVID-19 vaccination is required.

Biomedical Equipment Support Specialist I/II/

<h3>Job Description</h3>
Job Description
Position Summary:
We are seeking a detail-oriented and hands-on Secondary Operations Engineer / Process Engineer to join our medical tubing manufacturing team. This role is responsible for the development, validation, and continuous improvement of secondary operations processes to ensure high-quality, cost-effective production of medical-grade tubing products. The ideal candidate will bring strong technical skills, process engineering experience, and a deep understanding of quality standards within a regulated manufacturing environment.
Key Responsibilities:
<ul>
<li>Develop, implement, and optimize secondary operations for medical tubing, including cutting, hole punching, tipping, flaring, bonding, printing, molding and assembly.</li>
<li>Design and validate fixtures, tools, and equipment to support post-extrusion processes.</li>
<li>Collaborate with suppliers and equipment vendors for tooling design, maintenance, and upgrades.</li>
<li>Create, implement and maintain process documentation (work instructions, process flows, validation protocols, etc.).</li>
<li>Work with cross-functional teams (R&amp;D, Quality, Production) to support new product introductions and process scale-up.</li>
<li>Collaborate with Sales on evaluating and quoting new products, new product development and customer support. Participate in weekly review meetings to align capabilities with customer specifications.</li>
<li>Work with quality to conduct root cause analysis and lead corrective/preventive actions (CAPA) for process issues or non-conformances.</li>
<li>Train and support operators on new or revised secondary processes.</li>
<li>Follow and maintain a schedule of active projects and give necessary updates.</li>
<li>Drive continuous improvement and cost reduction initiatives using lean manufacturing and Six Sigma principles.</li>
<li>Facilitate project scale up activities including transferring manufacturing across multiple locations.</li>
</ul>
Qualifications:
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field.</li>
<li>5+ years of experience in medical device manufacturing or plastic tubing industry.</li>
<li>Hands-on experience with secondary operations processes and automation.</li>
<li>Familiarity with GMP, ISO 13485, and FDA regulations.</li>
<li>Strong troubleshooting skills and knowledge of statistical process control.</li>
<li>Experience with validation (IQ/OQ/PQ) and process documentation.</li>
<li>Excellent communication, documentation and project management skills.</li>
</ul>
Preferred Skills:
<ul>
<li>Experience with laser cutting, RF welding, or thermal bonding.</li>
<li>Proficient in CAD software (SolidWorks or similar) and Microsoft Office Suite.</li>
<li>Knowledge of polymer materials commonly used in medical devices (e.g., PVC, Pebax, Polyurethane).</li>
<li>Lean Six Sigma certification (Green Belt or higher).</li>
<li>Bilingual in Spanish, a plus</li>
<li>Prior Secondary Operations experience on molded or manufactured parts</li>
</ul>

Secondary Ops Engineer / Process Engineer

<h3>Job Description</h3>
Job DescriptionDescription:
Job purpose
 
The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields, and reduce variation. This position performs new process design and implementation, process validations and process qualifications. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&amp;D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.
 
Duties and responsibilities
 
<ul>
<li>Plan and execute process optimization, equipment qualification, and process validation or process qualification projects.</li>
<li>Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements.</li>
<li>Lead and perform equipment qualifications, process validations or process qualifications, including writing of protocols and reports.</li>
<li>Lead efforts to solve problems using formal problem resolution techniques and root cause analysis.</li>
<li>Create, communicate, and follow project plans with detailed tasks and timelines necessary for project completion. Communicate to management of performance against plan.</li>
<li>Identify and resolve insufficiencies in routine manufacturing and provide constant support to manufacturing team.</li>
<li>Develop standard operating procedures (SOPs) for newly designed or optimized processes, while ensuring compliance with safety and quality standards. </li>
<li>Assess processes, take measurements, and interpret data.</li>
<li>Develop and monitor process and equipment metrics to use for optimization analysis.</li>
<li>Comply with FDA and AATB tissue banking standards.</li>
<li>Other duties as assigned.</li>
</ul>
 
Requirements:
Qualifications
 
Qualifications include:
<ul>
<li>BS in Biomedical, Mechanical or Industrial Engineering or other applicable engineering discipline. Advanced degree (Master’s) a plus.</li>
<li>1-3 years of experience in Tissue Banking, Device, Biologics, or Pharmaceutical industry in a relevant engineering role preferred.</li>
<li>Strong analytical, planning, project management, critical thinking, troubleshooting, clear communication, and problem-solving skills.</li>
<li>Ability to effectively communicate with multidisciplinary teams. </li>
<li>Excellent technical skills and writing.</li>
<li>Strong knowledge of LEAN manufacturing principles preferred.</li>
<li>Working knowledge of 21 CFR 1271 regulations and AATB guidelines preferred.</li>
<li>Proficient in project planning software. Microsoft Project preferred.</li>
<li>CTBS certified (or certified within two years of employment).</li>
<li>Strong work ethics.</li>
</ul>
 
Working conditions
 
Job requires working in office. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing. 
 
Physical requirements
 
The job may entail the occasional requirement to stand for extended periods of time and lifting heavy objects of up to 30 lbs. and do repetitive tasks with few breaks while executing engineering plans.
 
Direct reports
No direct reports

Process Engineer I

<h3>Job Description</h3>
Job Description
Job Description:
<ul>
<li>
Cell Therapy Technical Operations (CTTO) is responsible for global product lifecycle strategy and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product lifecycle. 
</li>
<li>
The Senior Engineer will be responsible for the implementation of cell therapy manufacturing technologies, and process changes related to the life-cycle management of a commercial CAR-T Therapy. 
</li>
<li>
This includes establishing the strategy for process changes, coordinating technical alignment, and lead implementation at a global level. This role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement, rapid and best-in-class execution, and communication of challenges/opportunities.
</li>
<li>
Help drive the validation, qualification, and comparability strategies.
</li>
<li>
Lead the commercial lifecycle plan for a cellular product, maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.
</li>
<li>
Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
</li>
<li>
Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.
</li>
<li>
Provide technical content for significant documents such as validation activities, author content for regulatory submissions.
</li>
<li>
Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.
</li>
<li>
Provide necessary technical analysis to support impact assessments and investigations.
</li>
<li>
Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.
</li>
<li>
Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
</li>
<li>
Present complex technical topics internally and externally.
</li>
<li>
Share operational and process leanings with the rest of the manufacturing network
</li>
</ul>
Qualifications
<ul>
<li>
Bachelor's or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences with more than 5 years of experience in Biotech industry. 
</li>
<li>
Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
</li>
<li>
Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
</li>
<li>
Experience assimilating large data sets in support of batch history sections for regulatory submissions. 
</li>
<li>
Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.
</li>
<li>
Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
</li>
<li>
Ability to assess risk and develop contingency plans for process risks
</li>
<li>
Able to manage time and elevate relevant issues to project lead and line management.
</li>
<li>
Detail oriented with excellent verbal and written communication skills.
</li>
<li>
Strong interpersonal and leadership skills to work with teams in different functions and organizations
</li>
<li>
Proven ability to lead and drive projects within cross-functional teams, ensuring alignment and collaboration across multiple departments and organizations. 
</li>
<li>
A proactive and independent thinker.
</li>
<li>
Extensive experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs), Work Instructions (WIs), deviations, and Corrective and Preventive Actions (CAPAs) within a quality management system.
</li>
<li>
Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.
</li>
<li>
Ability to build strong relationships and a positive reputation with various teams and stakeholders.
</li>
<li>
Life Cycle Management Experience
</li>
<li>
Experience developing and implementing process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
</li>
<li>
Familiarity with cell therapy processes and cGMPs
</li>
</ul>
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. 
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. 
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.

Process Engineer

<h3>Job Description</h3>
Job Description
You have a Ph.D. in an Engineering discipline and 5+ years of Bioengineering/Biomechanics experience post-doctoral work. You want to use your training, education, and experience in a new and meaningful way.
Robson Forensic, a longstanding national forensic expert firm with an excellent reputation in the legal and scientific community, is looking for a Biomedical/Biomechanical Engineering Expert like you to provide investigation, analysis, reports, and testimony where technical and scientific answers are needed to help resolve civil and criminal litigation and insurance claims. 

 
Description:
 
Our Biomechanical Engineering Experts apply scientific and engineering principles of bioengineering and biomechanics to investigate incidents involving claimed injuries/fatalities due to an event. 
The areas of investigation may include impact and injury biomechanics/orthopedic biomechanics applied to events such as vehicle collisions, sports and recreation, occupation, assaults, falls etc. Additionally, we also apply our knowledge, experience, education, and training to evaluate medical device failures. 

 
Location:
 
PA
 
Requirements:
 
<ul>
<li>You have a Ph.D. in an engineering discipline. </li>
<li>You have a B.S. in Engineering from an ABET accredited University.</li>
<li>You have 5+ years of bioengineering/biomechanics experience post-doctoral work. </li>
<li>Your Traumatic Brain Injury (TBI) experience is a plus.</li>
<li>You can work both independently and as part of a comprehensive team.</li>
<li>You have excellent technical, analytical, writing, and communication skills.</li>
<li>You are willing to travel about 20% on average.</li>
</ul>
 
ABOUT US:
 
Robson Forensic is a national leader in expert witness consulting, providing technical expertise across many fields within engineering, architecture, science, and a broad range of specialty disciplines.
Employees at Robson Forensic work alongside highly respected experts from both industry and academia. Our forensic experts are engaged in meaningful casework that is consequential to industry and society. Robson Forensic provides a unique working dynamic that blends collaboration and autonomy.
 
HOW TO APPLY:
 
If you are looking for a challenging and rewarding position, and you meet our minimum requirements, please apply, and attach your resume and cover letter (outlining your professional background and expertise). We thank all applicants for their interest; however, only those under consideration will be contacted.
We are an Equal Opportunity Employer.

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