Position Summary: As a Design Assurance Engineer II, you will lead quality engineering activities for development projects from conception to commercialization. This includes developing risk management files, completing DHF deliverables, and being significantly involved in design verification/validation. You will also support design changes for commercial products, ensuring the quality, reliability, and compliance of mechanical product designs.
Key Responsibilities:
- Drive mechanical product design quality, reliability, and compliance to standards and regulations.
- Lead and support the on-time completion of design control deliverables.
- Critically evaluate mechanical product designs, identify potential quality issues, and drive issue resolution.
- Lead the preparation of risk management files and reports for product releases.
- Develop release testing plans for new products.
- Ensure DHF and DMR content completion, integrity, and regulatory compliance.
- Support quality system development and improvements.
- Establish objective, measurable, discrete, and verifiable customer and product requirements.
- Support print specification definitions, development, and changes.
- Develop and validate design test and inspection methods.
- Execute design verification/validation and reliability studies.
- Ensure on-time execution of Quality Plans for OEM manufacturing for development projects and design changes.
- Support manufacturing process development and qualification for new product commercialization and product changes.
- Participate in internal and external audits.
- Investigate complaints and significant product quality issues.
- Maintain strong collaborative partnerships with cross-functional team members and partner organizations.
Qualifications:
- Bachelor's degree in Engineering (Mechanical, Material Science, Biomedical) or related Science.
- 3+ years of relevant experience within the medical device industry or related function.
- Knowledge of GMP, ISO, QSR, and other applicable international regulations and standards.
- Strong statistical data analysis skills.
- Ability to manage multiple projects.
- Excellent verbal and written communication skills.
- Ability to work independently and in a cross-functional team environment.
- Customer-focused and service-oriented.
Preferred Qualifications:
- Design for Six Sigma and Critical to Quality training and experience.
- Background in sterile pharmaceutical products and drug-device combination products.
- Experience partnering with external organizations (customers and suppliers).
- Experience with participation in audits.
- ASQ certification.
