Senior Design Assurance Engineer

Position profile:

The Senior Design Assurance Engineer is a quality engineering role that supports new product development, sustaining engineering and post-market activities. Reporting to the Director, Operations Quality and Quality Systems, this role will provide quality engineering support to cross-functional teams to ensure the application and compliance to design controls and subsequent production and process controls are adequate. Specifically, this role will provide quality engineering support to the development of product technical documentation including requirements, product verification and validation, risk management, and design change control.

Responsibilities include:

• Work on a cross-functional team to identify and implement effective design controls and support product development from concept through commercialization.
• Understanding of Design Assurance requirements to support product design and design changes through cross-functional team collaboration, to ensure activities comply to all internal and regulatory requirements.
• Mentor cross functional teams through product development process; specifically, with respect to design control and risk management deliverables.
• Completes risk analysis studies of design and processes using FMEA and other Risk Management tools.
• Maintain up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
• Represent Quality by supporting quality disciplines, decisions, and practices.
• Liaise with departments, both internally and externally to build strong collaborative partnership.
• Support changes to DHF documentation.
• Review and approve design verification test plans, protocols and reports.
• Develop test method validation requirements.

• Utilize statistical analysis techniques to determine required level of product reliability and evaluate process capabilities.

• Provide Quality input to sustaining commercial product, process improvements and change control.
• Support cross functional team to develop protocols to ensure that design/process changes are adequately evaluated/tested with respect to standard requirements
• Plan, organize and prioritize own daily work routine to meet established schedule.

Required qualifications:

• Bachelor’s degree or higher in a technical field (Biomedical, Mechanical, Electrical, Software Engineering or other technical field)
• Comfortable working independently and as part of a cross-functional team
• Flexible and positive attitude, team-oriented
• Good communication skills (verbal and written), comfortable speaking and presenting to others
• Ability to manage multiple priorities and work with ambiguity
• Must be able to work independently under limited supervision
• Strong analytical skills

• Design Assurance work experience in the medical device industry

• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820

Preferred qualifications:

• Design assurance experience in medical device firmware
• Design assurance experience in medical device software
• Medical device cybersecurity experience