Job DescriptionPosition SummaryWe are seeking an experienced
Lab Project Specialist to lead the planning, development, and execution of verification activities for medical device products. This individual will serve as a technical expert in device testing, design inputs, risk analyses, and product requirements into robust verification strategies and test methods.
The ideal candidate possesses a strong engineering background, understands how medical devices function from both a design and user perspective, and can independently determine what testing is required to demonstrate that design requirements have been met. This role works closely with R&D, Lab, Quality, Regulatory Affairs, and external partners throughout the product development lifecycle.
Key ResponsibilitiesDesign Verification - Develop and execute design verification strategies for new and existing medical devices.
- Review product requirements, design inputs, and risk analyses to determine appropriate verification activities.
- Create verification protocols, test plans, acceptance criteria, and reports in compliance with applicable design control requirements.
- Ensure objective evidence is generated to demonstrate compliance with design requirements.
Test Method Development and Test Execution- Identify and implement appropriate measurement systems, instrumentation, fixtures, and data acquisition methods.
- Evaluate test method capability, repeatability, and reproducibility (e.g., GR&R).
- Develop custom test equipment and fixtures as needed.
- Support TMV and testing execution.
Data Analysis and Technical Reporting- Analyze test data using statistical and engineering methods.
- Support root cause analysis and recommend corrective actions.
- Prepare clear technical reports and present findings to project teams and management.
Cross-Functional Collaboration- Collaborate with Design Engineering, Quality, Regulatory Affairs, and Lab staff.
- Coordinate testing activities with external laboratories, consultants, and suppliers.
- Mentor junior engineers and provide leadership in verification and testing practices.
- Support overall project planning from a testing strategy perspective.
Compliance and Quality- Ensure verification activities comply with applicable standards, guidance documents, and internal procedures.
- Participate in Design Control, Risk Management, and Design History File (DHF) activities.
- Expertise in ISO 13485, ISO 14971
QualificationsRequired Qualifications- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or related discipline.
- 3+ years of experience in medical device development, verification, testing, or systems engineering.
- Demonstrated experience developing verification strategies and executing design verification programs.
- Strong understanding of medical device design controls and product development processes.
- Experience developing test methods and analyzing data.
- Excellent technical writing and communication skills.
- Ability to independently assess designs and determine appropriate verification approaches.
- Ability to work in a lab and/or clean room environment requiring PPE
Preferred Qualifications- Experience with inhalation, drug delivery, combination products, surgical, diagnostic, or other complex medical devices.
- Knowledge of risk management and failure analysis methodologies.
- Experience with statistical analysis tools such as Minitab, JMP, or equivalent.
- Familiarity with IEC 60601, ISO 11608, or other applicable medical device standards.
- Experience managing external test laboratories and contract development partners.
Additional InformationPOSITION RANGE: $85,000- $115,000 USD Salaried (This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.)
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