Design Assurance Engineer

Kaye/Bassman International; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Kaye/Bassman International is seeking a Design Assurance Engineer to ensure product quality and regulatory compliance for Class II electro-mechanical medical devices. The role will drive design controls, risk management, and cross-functional collaboration to deliver safe, effective products.

The position includes supporting design verification/validation, documentation, and interactions with external test houses and regulatory bodies.

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, regulations, and standards (FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, IEC 62304).
• Experience supporting medical device compliance testing with external test houses (e.g., TUV, Intertek).
• Experience maintaining technical design documentation (design specs, verification/validation protocols, DFMEA/PFMEA).
• Experience with lasers and optical technologies is desirable but not required.
• Strong MS Word and Excel proficiency.

Responsibilities

• Conduct product design control activities for new and sustaining product development.
• Support risk analysis activities including design and process FMEA.
• Support design verification and validation activities, including software validation and IQ/OQ/PQ processes.
• Maintain technical design documentation (design specs, verification/validation protocols, DFMEA/PFMEA).
• Assist Regulatory with FDA, CE, and other regulatory submissions as needed.
• Coordinate with third-party test houses for product compliance testing.

Skills

Design Controls

Risk Management

FDA QSRs

ISO 13485

ISO 14971

IEC 60601

IEC 62304

DFMEA/PFMEA

Statistical methods

Laser/Optics knowledge

MS Word & Excel

Education

Bachelor's degree in engineering or science

Tools

Minitab

Microsoft Word

Microsoft Excel

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.