Senior Design Assurance Engineer

Kaye/Bassman International; Boston (MA); On-site; USD 120,000 - 165,000; Full time

Job summary

Kaye/Bassman International is partnering with a growing medical device company to hire a Senior Design Assurance Engineer in the Boston area. The role emphasizes design controls, risk management, and compliance testing across the product lifecycle.

You will work with R&D, Regulatory, and Manufacturing to uphold robust design assurance practices and drive continuous improvement. The ideal candidate brings 8+ years in an engineering or quality role within medical devices, with strong knowledge of

Qualifications

• Bachelor's degree in a scientific or engineering field is required.
• Strong knowledge of Design Controls and Risk Management, including FDA QSRs and ISO standards.
• Experience supporting regulatory submissions (FDA, CE) and harmonized standards.

Responsibilities

• Lead and conduct design control activities for new product development and sustaining engineering.
• Support risk analysis, including development and maintenance of DFMEA and PFMEA.
• Partner with cross-functional teams on design and process validation/verification, including software validation and IQ/OQ/PQ protocols.
• Collaborate with Design Engineering to create and maintain Design History Files and Technical Files.
• Coordinate with third-party test houses to ensure compliance testing is executed and documented properly.
• Assist Regulatory Affairs with FDA, CE, and other global submissions.
• Ensure adherence to applicable regulatory requirements, company policies, and quality standards.

Skills

Design Controls

Risk Management

Regulatory Submissions

Statistical Analysis

Minitab

Education

Bachelor's degree in a scientific or engineering field

Tools

Minitab

Job description

My client is a growing medical device company at the forefront of laser-based precision technologies that directly improve patient care. They are seeking a Senior Design Assurance Engineer to ensure their products meet regulatory requirements, quality standards, and customer expectations.

This hands-on technical leadership role focuses on design controls, risk management, and compliance testing across the product lifecycle. You will partner closely with R&D, Regulatory, and Manufacturing to keep design assurance practices robust, support regulatory submissions, and drive continuous improvement.

• Lead and conduct design control activities for new product development and sustaining engineering
• Support risk analysis, including development and maintenance of DFMEAs and PFMEAs
• Partner with cross-functional teams on design and process validation/verification, including software validation and IQ/OQ/PQ protocols
• Collaborate with Design Engineering to create and maintain Design History Files and Technical Files
• Coordinate with third-party test houses to ensure compliance testing is executed and documented properly
• Assist Regulatory Affairs with FDA, CE, and other global submissions
• Ensure adherence to applicable regulatory requirements, company policies, and quality standards
• Bachelor's degree in a scientific or engineering field
• 8+ years in an engineering or quality role within the medical device industry
• Strong knowledge of Design Controls and Risk Management, including FDA QSRs, ISO 485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, and IEC 62304 (preferred)
• Experience supporting compliance testing (EMC, EMI, IEC) with external test houses such as TÜV or Intertek
• Proven ability to maintain design specifications, V&V protocols, and DFMEA/PFMEA
• Working knowledge of advanced statistics (hypothesis testing, DOE, ANOVA, R&R, capability analysis, tolerance intervals, power and sample size), with Minitab preferred
• Lasers and optical technology experience is a plus, but not required