Design Quality Engineer

Quality Assurance Engineer

Design Quality Assurance Engineer will be a multi-site and oversee engineering support required for all new product development and lifecycle management projects. This position will support a global deployment of Design Controls procedures and is responsible for ensuring projects are adequately staffed to achieve required milestones. This individual will collaborate and partner with peers and senior leadership in other organizations, including Research & Development, Regulatory, Marketing, Supply Chain and Manufacturing Operations.

Responsibilities include but not limited to:

• Design quality engineer on new product development cross-functional core team
• EU MDR remediation support
• Responsible for risk management planning, use/design failure mode effects analysis (FMEA), risk control and mitigation and verification of effectiveness.
• Responsible for quality design transfer activities including test method validation / measurement systems analysis and incoming inspection. Support other design transfer activities, including process validations, master validation plans, process summaries, and process failure mode effects analysis (FMEA).
• Responsible for development and release of engineering design documentation, support core team during design reviews and support design history file compilation/audit activities.
• Provide quality input to product user needs, design inputs, design specifications and design outputs (including analysis/definition of critical to quality features).
• Support design verification testing, design validation and usability testing.
• Attend cadaveric labs with customers (sales, marketing, surgeons) to build understanding of user needs and conduct design validation/usability.
• Assists in preparation for regulatory submissions and support sustaining quality with defending design control elements during internal and external audits. Includes leading design control gap assessments (DHF audits).
• Assist in identification and implementation of process improvement initiatives which require cross-functional and multi-site collaboration.
• This role will also be required to support other aspects of the QMS, including Quality Systems, Post Market Surveillance and Supplier Quality.

Required knowledge, skills and abilities:

• Familiarity with the FDA, ISO, MDD/MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Understanding and working knowledge of US and International regulations including 21CFR820, 803, 50, and 11 is required, as well as the Medical Device Directive/Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).

Minimum required education and experience:

• 3+ years of medical device engineering experience.
• BS in Mechanical, Electrical, or Biomedical Engineering.