Senior Quality Engineer - Future Forward / NPD

About the role

The primary function of this position is to support the projects associated with the development of next-generation surgical systems. The role requires a strong quality functional leader who contributes to design controls, risk management, process validation, and design for reliability and manufacturing.

Responsibilities

• Contribute to the planning and execution of design controls, risk management, and design verification/validation for new products.
• Support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.
• Translate user needs into the design while complying with usability and human factors standards and regulations.
• Define design inputs, design outputs, and traceability matrices.
• 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.
• Aid 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.

Qualifications

• Minimum of 8 years of related experience with a University Degree (in Electrical Engineering, Mechanical Engineering, Computer Science, software engineering, biomedical engineering), or 6 years of relevant experience and an Advanced Degree.
• Strong proficiency in FDA Design Controls and international standards, including ISO 13485, ISO 14971, and IEC 60601/62304.
• Experience working with robotic or complex electromechanical devices is preferred.
• Previous experience with reliability principles, testing, reliability growth planning, and execution is preferred.
• Previous experience with running Verification & Validation 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.
• Certifications such as ASQ CQE, ASQ CRE, or Six Sigma Black Belt are preferred.