Design Assurance Engineer

Kaye/Bassman International; Massachusetts; On-site; USD 85,000 - 125,000; Full time

Job summary

Kaye/Bassman International is recruiting for a Design Assurance Engineer in Massachusetts. The role focuses on ensuring product quality and regulatory compliance through robust design control and risk management across new and sustaining medical device development.

The candidate will support design validation/verification, maintain technical documentation, and coordinate with external labs for regulatory testing, with emphasis on FDA QSRs and ISO standards.

Qualifications

• Bachelor's degree in engineering or sciences required.
• 3–5 years in Class II electro-mechanical medical devices.
• Knowledge of FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, IEC 62304 preferred.
• Experience coordinating regulatory testing with external labs (EMC/EMI).
• Design Controls and Risk Management knowledge required; proficiency in documentation.

Responsibilities

• Lead design control activities for new and sustaining products.
• Support risk analysis including DFMEA/PFMEA.
• Validate and verify processes, incl. software validation and IQ/OQ/PQ.
• Maintain design history files and technical documentation.
• Coordinate with third‑party test houses for regulatory testing.
• Assist regulatory with FDA/CE submissions.

Skills

Design controls

Regulatory compliance

Risk management

Statistical methods

Minitab

Microsoft Word

Microsoft Excel

FDA QSRs

ISO 13485

Education

Bachelor's degree in engineering or sciences

Tools

Minitab

Regulatory testing coordination

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.