Design Assurance Engineer

The Judge Group; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

The Judge Group seeks a Design Controls Engineer in Marlborough, MA to conduct product design control activities for new and sustaining product development. You will support risk analysis, including design and process FMEA, and assist with design history files, regulatory submissions, and third-party testing coordination with FDA and ISO standards compliance.

The role requires 3–5 years of experience with Class II electro-mechanical medical devices and uses tools like Minitab, Word, and Excel to

Qualifications

• Bachelor's degree in a scientific or engineering field, electrical engineering preferred.
• 3-5 years of experience in engineering and development of Class II electro-mechanical medical devices.
• Knowledge of Design Controls and Risk Management practices per FDA QSRs, ISO 13485, ISO 14971, IEC 60601/60601-1, IEC 62366/62304 preferred.
• Experience supporting regulatory testing (EMC/EMI/IEC) with external test houses and maintaining design documentation (DFMEA/PFMEA).

Responsibilities

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

Education

Bachelor's Degree in engineering (electrical preferred)

Tools

Minitab

Microsoft Word

Microsoft Excel

Job description

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

JOB REQUIREMENTS:

Education and Experience

• Bachelor's Degree in 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, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred
• Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek
• Maintenance of 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, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred
• Strong working knowledge of Microsoft Word and Excel