Senior Quality Engineer – Design Controls and V&V

Senior Quality Engineer – Design Controls and V&V

Requirements

• Requires a minimum of 8 years of related experience with a University Degree (in Electrical Engineering, Mechanical Engineering, Computer Science, software engineering, biomedical engineering), or 5 years of relevant experience and an Advanced Degree
• Expertise in medical device standards such as ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, and FDA Design Controls. Previous experience risk-based V&V, process validation, limit/challenge testing is required
• Ability to navigate quality systems with minimal oversight on individual projects
• Balanced risk decision-making to drive product quality, gain consensus, and work through technical challenges
• Ability to solve complex problems with minimal oversight. Ability to articulate complex information to teams, including executive management.

Responsibilities

• Contribute to the planning and execution of design controls, risk management, and design verification/validation for new products.
• Participate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.
• Understand user needs and ensure they are translated into the design, while complying with usability and human factors standards and regulations.
• Partner with engineering to define design inputs, design outputs, and traceability matrices.
• Contribute to the strategy and execution of risk-based design verification and validation.
• Participate in and support the development of the product risk management file, analyzing and assessing product risks associated with user, design, process, and supplier.
• Ensure reliable and scalable designs are transferred to manufacturing.
• Review design architectures, selections, requirements, and drawings from early design stages.
• Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transfer of scalable designs into production.
• Assist in supplier selection, qualification, certification, and performance improvement.
• Contribute to new product development Technical Reviews and Design Reviews.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Support internal and external audits, including preparation and direct interaction with auditors.
• Support continuous improvement in design control & risk management quality processes and methodologies.

Preferred Qualifications

• Previous experience with reliability principles, testing, reliability growth planning, and execution is preferred
• Previous experience with running Verification & Validation Testing is preferred