Role: Sr. Development Quality Engineer - Medical Devices
Location: Westford, MA - 1886
Duration: 12 Months
The Senior Development Quality Engineer serves as the technical quality representative supporting product development teams. This role provides design quality expertise across the entire product lifecycle to ensure patient and user safety, regulatory compliance, and customer satisfaction.
The position partners closely with cross-functional stakeholders to deliver compliant, high-quality medical devices from concept through commercialization, while ensuring adherence to regulatory and quality system requirements.
Key Responsibilities
- Lead or support the completion of design control documentation in accordance with regulatory requirements.
- Collaborate with cross-functional teams to establish clear, measurable, and verifiable product requirements.
- Support design verification and validation (V&V) planning, execution, and issue resolution.
- Lead risk management activities, including risk assessments and mitigation strategies throughout the product lifecycle.
- Support test method development and lead test method validation activities.
- Work closely with manufacturing teams on process development and qualification for new or updated product designs.
- Support component specification development, supplier sampling plans, and vendor qualification activities.
- Assist with biocompatibility and sterilization qualification processes.
- Participate in internal and external audits and contribute to continuous quality system improvements.
- Ensure compliance with quality systems, regulatory standards, and industry guidelines.
- Maintain effective communication with internal teams, suppliers, contractors, and customers.
Required Technical Skills
- Experience supporting or leading design control deliverables, risk assessments, and FMEA activities during product development.
- Expertise in test method development, validation, and execution of design verification and validation (V&V) activities.
- Strong knowledge of medical device regulatory requirements and quality systems, including FDA and EU MDR compliance, audits, and regulatory standards.
- Excellent written and verbal communication skills with the ability to collaborate effectively across teams.
Qualifications
- Bachelor’s degree in Engineering or a related technical field (required).
- Advanced degree in Engineering or a technical discipline (preferred).
Experience
- 2–5 years of experience supporting medical device product development.
- Experience working with Class II medical devices preferred.
- Exposure to imaging device development projects is highly desirable.Project Details
- The role will support new product development initiatives.
- Current projects focus on Class II imaging devices with multiple imaging-related development programs in progress.
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