Design Assurance Engineer

ipgjobs; Marlborough (MA); On-site; USD 95,000 - 130,000; Full time

Job summary

IPG Photonics seeks an experienced Design Validation Engineer to lead design controls activities for medical devices, sustaining development, and regulatory submissions in a fast-paced environment.

You will collaborate with design engineering, perform DFMEA/PFMEA and risk analyses, work with external labs for testing, and ensure compliance with FDA QSRs, ISO 13485, IEC 60601 and related standards while using Minitab for statistical analyses.

Qualifications

• Bachelor's degree in a scientific or engineering field; electrical engineering 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, FDA QSRs, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, 62304 is preferred.
• Experience with regulatory testing with external test houses (EMC, EMI, IEC).
• Maintenance of technical design documentation (design specs, verification/validation protocols, DFMEA/PFMEA).
• Experience with statistical methods and software tools (e.g., Minitab) is preferred.
• Lasers and optical technologies experience is a plus; strong Word/Excel skills.

Responsibilities

• 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 IPG products
• Assist regulatory department with FDA, CE, and other regulatory submissions
• Perform all other essential duties as assigned

Skills

Design Controls

Risk Management

Regulatory standards

DFMEA/PFMEA

Regulatory submissions

Statistical methods

Education

Bachelor's Degree in engineering or scientific field; electrical engineering preferred

Tools

Minitab

Job description

Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

Job Function

• 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 IPG products
• Assist regulatory department with FDA, CE, and other regulatory submissions
• Perform all other essential duties as assigned

• 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
• Experience with lasers and optical technologies desired, but not necessary
• Strong working knowledge of Microsoft Word and Excel