Job Summary:

This role is responsible for leading the Supplier Quality Engineering function and driving the technical quality and engineering performance of Nova Biomedical's supply base throughout product lifecycle activities, including design transfer, supplier process qualification, incoming inspection, manufacturing engineering support, engineering validation, and continuous improvement. This position partners closely with Research & Development Engineering, Manufacturing Engineering, Operations, and suppliers to ensure robust engineering processes, effective risk management, and consistent delivery of high-quality components and materials that meet product, engineering, and regulatory requirements.

Responsibilities:

• Lead and develop a team of Supplier Quality Engineers responsible for supplier qualification, process validation, and ongoing supplier engineering performance improvement.
• Provide engineering and technical oversight of supplier quality engineering activities throughout design transfer, new product introduction (NPI), manufacturing, and sustaining operations.
• Partner with Research & Development Engineers, Manufacturing Engineers, Supplier Development Engineers, and Operations teams to evaluate and qualify suppliers, manufacturing processes, and critical components.
• Drive Advanced Product Quality Planning (APQP) activities and risk-based engineering qualification strategies for new suppliers and components.
• Lead supplier process validation and engineering qualification efforts, including IQ/OQ/PQ activities, process capability studies, and manufacturing readiness assessments.
• Apply engineering principles, statistical methods, and quality engineering tools to assess supplier process capability, identify sources of variation, and drive continuous improvement.
• Utilize engineering risk management principles consistent with ISO 14971 to assess supplier-related risks and implement effective mitigation strategies.
• Drive engineering root cause investigations for supplier-related nonconformances using structured problem-solving methodologies such as 8D, DMAIC, Fishbone Analysis, and Five Whys.
• Lead disposition, investigation, and trend analysis of supplier-related Non-Conforming Material Reports (NCMRs) and implement systemic corrective actions.
• Issue and manage Supplier Corrective Action Requests (SCARs), ensuring sustainable engineering solutions are implemented and verified through effectiveness reviews.
• Analyze supplier quality and process engineering data to identify trends, reduce defects, improve process capability, and enhance supply chain robustness.
• Support design transfer activities by ensuring suppliers meet manufacturing, quality, engineering, and regulatory requirements before product launch.
• Evaluate supplier changes for potential impact to product quality and manufacturing engineering processes, ensuring appropriate validation and risk assessment activities are completed.
• Collaborate with suppliers to improve process controls, inspection strategies, yield performance, manufacturing efficiency, and engineering capability.
• Conduct supplier technical and engineering assessments, including on-site evaluations of manufacturing processes, process controls, validation practices, and engineering capabilities.
• Serve as the Supplier Quality Engineering subject matter expert during internal audits, regulatory inspections, and ISO 13485/MDSAP/IVDR certification audits.

Experience Requirements:

• Bachelor's degree in Engineering, such as Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, Chemical Engineering, or a related engineering discipline required.
• Minimum of 7+ years of progressively responsible engineering experience in Supplier Quality Engineering, Manufacturing Engineering, Quality Engineering, Process Engineering, or a related technical engineering role within a regulated industry.
• Previous people leadership or engineering management experience.
• Strong understanding of manufacturing processes, process controls, validation methodologies, and engineering problem-solving techniques.
• Proven engineering experience qualifying suppliers, manufacturing processes, and critical components.
• Demonstrated success driving supplier defect reduction and process capability improvements using data-driven engineering methodologies.
• Working knowledge of statistical quality engineering tools, including SPC, process capability analysis, DOE, sampling plans, and trend analysis.
• Experience conducting engineering root cause investigations and implementing effective corrective and preventive actions with suppliers.
• Strong knowledge of engineering risk management principles and application of ISO 14971 in supplier and manufacturing environments.
• Working knowledge of ISO 13485, MDSAP, FDA Quality System Regulation, and supplier quality requirements within medical device or life sciences industries.
• Experience supporting design transfer, process validation, manufacturing scale-up, and new product introduction activities.
• Strong technical engineering communication skills with the ability to influence suppliers, engineering teams, and cross-functional stakeholders.

Physical Requirements and Working Conditions:

• Ability to carry up to 25 pounds.
• Ability to work at a desk for extended periods.
• The full list of physical requirements for this role is available upon request.

Flexible Medical, Dental, & Vision Coverage

Competitive 401k company match

Bonus Program, Generous PTO and paid holidays

Generous Tuition reimbursement

Hybrid and flexible work arrangements

Professional development, engagement and events

Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices

Company subsidized cafeteria in our Waltham, MA office

Work Location: Hybrid in Waltham, MA

Schedule/Hours: Monday to Friday, 8:30 AM • 5:00 PM

Targeted Salary Range: $130,000 - $150,000/year

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.