Senior Design Quality Assurance Engineer - Endoscopy

The Senior Design Quality Assurance Engineer directly supports medical device product development from concept through commercialization. This individual will work with high-performing cross-functional development team to ensure safety, quality and compliance of our products while continuously improving their commercial value. The position is part of the design site for the Endoscopy Division and supports activities such as New Product Development, Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development. This is a hybrid position based out of Marlborough, MA with a minimum of three days per week onsite.

Your responsibilities include:

• Act as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices.
• Lead the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change, and Design & Usability Validation Plans. Leads the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Guides the successful completion of major programs and may function in a project leadership role.
• May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources. Acts as division representative on cross-divisional projects defining the quality system(s).
• Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Applies systematic approaches (e.g. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
• Guides and mentors engineers, fostering a culture of learning, collaboration, and technical excellence. Provides coaching on quality engineering methodologies and problem-solving techniques.
• Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders. Uses influence and negotiation skills to integrate quality perspectives into business decisions.
• Identifies and implements best-in-class practices for the department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.
• Supports internal and external regulatory audits as audit facing subject matter expert as required. Supports regulatory responses through technical writing and submission consultation as required.

What we're looking for in you:

Required Qualifications

• BS in Biomedical Engineering, Mechanical Engineering or related degree.
• 5+ years of medical device engineering experience.
• Detailed understanding and working knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Preferred Qualifications

• 6+ years of medical device engineering experience.
• Proficiency in Minitab Statistical Analysis software or equivalent.
• Six Sigma Certification.
• Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence teams and leadership.
• Proven ability to lead and coach others, driving a high-performance quality culture.
• Strategic mindset with hands-on execution, balancing long-term objectives with immediate project needs.