About the position

As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical devices. This senior-level position requires you to work closely with device development teams, medical device suppliers, and testing partners during the design and development phases, extending your support throughout the device lifecycle. Your expertise will drive the development, implementation, and continuous improvement of device-related quality processes and procedures, ensuring compliance with relevant standards and regulatory requirements. By providing strategic guidance and oversight, your role will be integral to the product quality and integrity across all modalities within the organization. This is a hybrid role that can be located either in Research Triangle Park, NC or Cambridge, MA.

Responsibilities

• Lead quality engineering guidance and oversight for medical devices and combination products during feasibility, design control, risk management, and lifecycle management.
• Define critical quality characteristics for device components and finished devices in collaboration with the device development team.
• Support internal and external audits as a device or combination product Subject Matter Expert.
• Oversee the quality review and approval of technical documentation, ensuring compliance with regulatory requirements.
• Provide input to process manufacturing design and design transfer for robust product realization.
• Support asset team strategies for regulatory filings, design control, and risk management.
• Lead continuous improvement initiatives for the Quality Management System and lifecycle processes.
• Function as the quality representative on cross-functional initiatives and device development programs.
• Manage quality assurance interfaces with medical device suppliers and testing partners in collaboration with External Quality.

Requirements

• Minimum of a BS in Biomedical/Mechanical Engineering or related technical or scientific discipline.
• At least 7 years of experience in medical device and/or combination product industries.
• Extensive knowledge of design control and risk management for medical devices.
• Strong understanding of regulatory requirements and quality standards.
• Excellent communication and collaboration skills.
• Proven ability to lead cross-functional teams and initiatives.
• Experience in leading continuous improvement initiatives within a Quality Management System.
• Familiarity with medical device supplier and testing partner management.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to \$10,000 per calendar year
• Employee Resource Groups participation