Design Assurance Engineer

Kaye/Bassman International; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

The Design Assurance Engineer at Our client will drive design controls, risk management, and regulatory compliance for Class II electro‑mechanical medical devices. You will collaborate across functions to ensure quality, traceability, and robust verification and validation activities, including software validation and DFMEA/PFMEA.

Candidates should hold a bachelor’s degree in a scientific or engineering field, 3–5 years of relevant experience, and familiarity with FDA QSRs, ISO 13485, ISO 14971,

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 3–5 years of experience with Class II electro‑mechanical medical devices.
• Knowledge of Design Controls and Risk Management practices, FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304.
• Experience coordinating medical device compliance testing with external labs (e.g., TUV, Intertek).
• Proficiency in Microsoft Word and Excel; familiarity with statistical tools is a plus.

Responsibilities

• Conduct design control activities for new and sustaining product development.
• Support risk analyses, including DFMEA/PFMEA.
• Assist design verification/validation activities, including software validation and IQ/OQ/PQ.
• Maintain technical design documentation and DHF/Technical Files.
• Coordinate with third‑party test houses for regulatory testing.
• Assist regulatory with FDA/CE submissions.
• Collaborate with cross‑functional teams to ensure high design and safety standards.

Skills

Design Controls

Risk Management

Regulatory Compliance

FDA QSRs/ISO 13485

Statistical Methods

Education

Bachelor's Degree in scientific or engineering field

Tools

Minitab

Job description

Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. With a commitment to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose and help shape the future of medical technology.

Position Summary:

The Design Assurance Engineer will play a critical role in ensuring product quality and regulatory compliance through robust design control and risk management practices. This position will support new and sustaining product development efforts, collaborating cross-functionally to maintain the highest medical device design and safety standards.

Join a team where startup-style medical device growth is backed by the resources and stability of an established global technology leader and help shape the future of medical technology.

Responsibilities

• Conduct product design control activities for both new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation and Verification activities, including software validation and IQ/OQ/PQ processes.
• Maintain technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Support Design Engineering in the creation of Design History Files and Technical Files.
• Interact with and coordinate with third-party test houses that conduct product compliance testing.
• Assist the regulatory department with FDA, CE, and other regulatory submissions.
• Perform all other essential duties as assigned.

Requirements

• Bachelor's Degree in a scientific or engineering field; electrical engineering is preferred.
• 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices.
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, including FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, and IEC 62304, is preferred.
• Experience supporting medical device compliance testing (e.g., EMC, EMI, IEC) with external test houses, such as TUV and Intertek.
• Experience maintaining technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability analysis, tolerance interval analysis, power and sample size determinations) and statistical software tools such as Minitab is preferred.
• Experience with lasers and optical technologies is desired, but not necessary.
• Strong working knowledge of Microsoft Word and Excel.