Sr. Development Quality Engineer

1. Design Controls & Risk Management Proven experience leading and supporting design control deliverables, risk assessments, and FMEAs throughout product development. 3. Medical Device Quality & Regulations Strong working knowledge of FDA, EU MDR, and medical device quality system requirements, including audits and compliance activities.

Title: Sr. Development Quality Engineer
Location: Westford, MA 01886
Duration: 10 Months

Position Purpose and Scope:
The Sr. Development Quality Engineer serves as a technical quality representative supporting product development teams. This role provides design quality expertise across the 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.
Top 3 Technical Skills:
1. Design Controls & Risk Management Proven experience leading and supporting design control deliverables, risk assessments, and FMEAs throughout product development.
2. Verification, Validation & Test Methods Expertise in test method development, validation, and execution of design verification and validation activities.
3. Medical Device Quality & Regulations Strong working knowledge of FDA, EU MDR, and medical device quality system requirements, including audits and compliance activities.
Additional Requirement: Clear and effective communication skills are a must.
Education:
Bachelor s degree in Engineering or a related technical field (required).
Advanced degree in Engineering or a technical field (preferred).
Experience / Project Details:
Minimum 2 5 years of experience supporting medical device product development
Project focus: Class II imaging device
This role will support new product development, with multiple imaging-related projects in progress
Day-to-Day Responsibilities:
Lead or support timely completion of design control documentation
Collaborate with cross-functional teams to establish clear, measurable, and verifiable product requirements
Support design verification and validation planning, execution, and issue resolution activities
Lead risk management activities from product concept through commercialization
Support test method development and lead test method validation efforts
Collaborate with manufacturing on process development and qualification for new or updated designs
Support component specification development, supplier sampling plans, and vendor qualification activities
Support biocompatibility and sterilization qualifications
Participate in audits and continuous quality system improvement initiatives
Ensure compliance with Client quality systems, FDA, EU MDR, and other applicable regulatory requirements
Maintain effective communication with employees, suppliers, contractors, and customers