
Senior Mechanical Design Engineer
1 week ago
Design Verification and Reliability Strategist
Job Description:
- Develop technical interfaces between drug product and device teams during combination product development.
- Create design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
- Design test methods and specifications to assess device functionality and product performance.
- Material assessment of device components, including biological evaluation, extractables profiling and material certification.
Responsibilities Include:
- Leading a team to plan and execute design verification and reliability strategies.
- Working closely with cross-functional teams to ensure formulation and manufacturing development activities are compatible and align with device development.
- Developing analytical methods and applying statistical techniques for data analysis.
Requirements:
- Master's degree in Science or Engineering.
- At least 7 years' experience in pharmaceutical and/or medical device development.
- Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 is an advantage.
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