Design Assurance Engineer

IPG Photonics Corporation; Marlborough (MA); On-site; USD 75,000 - 99,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Employee stock purchase plan

Tuition reimbursement

Life insurance

Disability insurance

Job summary

IPG Photonics in Marlborough, MA is seeking a design engineering professional to lead development and validation of Class II electro-mechanical medical devices. You will design controls, support risk management, and collaborate with regulatory teams.

This exempt role requires a Bachelor's degree in engineering, 3–5 years of relevant experience, and strong skills in Design Controls, risk management, and DOE/statistical methods using Minitab.

Qualifications

• Bachelor's degree in science or engineering (electrical preferred)
• 3–5 years of experience in engineering and development of Class II electro-mechanical medical devices
• Knowledge of Design Controls and Risk Management per FDA QSR, ISO 13485, ISO 14971, IEC 60601 etc.
• Experience with regulatory testing (EMC/EMI/IEC) with external test houses
• Maintenance of design history files and DFMEA/PFMEA; statistical methods knowledge (DOE, ANOVA) using Minitab

Responsibilities

• Conduct product design control activities for new and sustaining products
• Support risk analysis activities including DFMEA/PFMEA
• Assist with design validation/verification including software validation
• Create and maintain Design History and Technical Files
• Interact with test houses for regulatory testing (FDA/CE)
• Assist regulatory submissions to FDA, CE, and others
• Perform other duties as assigned

Skills

Class II medical devices

Design Controls

Risk Management

Regulatory standards

DOE/ANOVA

Minitab

Excel

Word

Education

Bachelor's Degree in engineering (electrical preferred)

Tools

Minitab

Microsoft Word

Excel

Job description

Marlborough, Massachusetts, United States

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

Requirements

• 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

Location(s)

225 Cedar Hill Street, Marlborough , Massachusetts 01752 , United States

Employment Type

Exempt

Wage Information

MA: $74,956 - $99,316

US Benefits Information

Pay Range:

The pay range on this posting applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location posted, the applicable range could differ. Actual starting pay is determined by a number of factors including relevant skills, qualifications, and experience.

Other Compensation: Employees in this role are eligible for additional rewards which could include:

• Annual Discretionary Bonus or Sales Bonus as Applicable

Benefits Provided: All Regular* US employees receive:

• Paid vacation time accrued based on years of service

*Prorated for reduced hour schedules

Additional Benefits Offered: IPG also offers access to:

• Medical, dental, and vision insurance plans with options for HSA/FSA
• Dependent Care FSA
• Paid Basic Life and AD&D Insurance
• Short-term and Long-term Disabilityinsurance
• 401(k) plan with Company matching
• Employee Stock Purchase Plan (ESPP)
• Tuition Reimbursement Program
• Employee Assistance Program (EAP)
• Adoption Assistance
• Pet Insurance
• Bright Horizons Backup Care
• Bright Horizons College Coach

*Benefits eligibility may differ by program for reduced hour schedules

EEO is the Law