The Design Assurance Engineer provides technical engineering support to post market / sustaining engineering teams and new product development in the medical device industry.
This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to these post market / sustaining and development efforts, as a member of one or more cross-functional development team(s).
Risk Management background, preferably Medical Device. Should have good technical writing abilities. Should be familiar with DFMECA, and other Med Device Quality terminology.
• Supports post market / sustaining engineering efforts on commercialized products
• Identifies and manages risk throughout the development process and sustaining efforts with the use of FMECA, Post-Market Surveillance Reports, Periodic Safety Update Report, Risk Management Plans/Reports, and other risk management tools including new EU MDR requirements.
• Participates in corrective/preventive action teams to resolve systemic issues. Partners with cross-functional peers to resolve product performance issues (NCRs, CAPAs, deviations, manufacturing process problems etc.) and to assess impact on device quality and product availability.
• Partners with multiple manufacturing sites and external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance.
• Participates in product development process to include design verification, design validation, process validation and other activities as needed.
Experience with Canadian Medical Device Regulation (CMDR); EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Device Regulation, ISO 13485, and ISO 14971 a plus