Sr. Assurance Design Engineer - Framingham, MA

The Sr. Design Assurance Engineer will lead product design control activities for new and sustaining medical device development, ensuring compliance and managing risk analysis. They will collaborate with cross-functional teams to support validation, verification, and regulatory submissions, contributing to the successful launch of innovative medical technologies.

Client Details

My client specializes in developing cutting-edge medical devices using advanced laser technology to enhance patient care. They are committed to innovation, sustainability, and building a diverse, engaged workforce to drive future success.

Description

Responsibilities:

• Leading product design control activities for both new and sustaining product development efforts.
• Supporting risk analysis, including design and process FMEA.
• Assisting with Process/Design Validation and Verification activities, including software validation and IQ/OQ/PQ processes.
• Collaborating with Design Engineering to create Design History and Technical Files.
• Coordinating with third-party test houses for compliance testing of products.
• Assisting the regulatory team with FDA, CE, and other regulatory submissions.
• Performing other essential duties as assigned.

Profile

Ideal Candidate:

• Bachelor's Degree in a scientific or engineering discipline.
• At least 8 years of experience in an engineering or quality role within the medical device industry.
• Strong experience with design control processes and design verification, including maintaining internal design controls.
• Ability to understand and manage product requirements, with a solid background in Risk Management.
• Experience with both disposable and capital equipment, particularly with complex disposables (e.g., electrochemical devices).
• Proven ability to maintain and structure design history throughout the development process.
• Heavy experience in the development phase of the product lifecycle, with hands-on experience in driving products through this phase.
• Familiarity with key regulations and standards (e.g., FDA QSR, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, 62304) is preferred.
• Experience supporting medical device compliance testing (e.g., EMC, EMI, IEC) with external test houses such as TUV and Intertek.
• Proven ability to maintain technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Proficiency in advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability analysis, tolerance intervals, power/sample size calculations), with experience using statistical software tools like Minitab preferred.
• Experience with lasers and optical technologies is a plus, but not required.
• Stability and focus, with the ability to remain steady in long-term projects and avoid frequent role changes.

Job Offer

What's To Offer:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.