Design Assurance Engineer

Entegee; Southborough (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Term life insurance

Short-term disability insurance

Additional voluntary benefits

Commuter benefits

401K plan

Paid Sick Leave

Holiday pay

Job summary

Entegee is seeking an engineer to ensure that designs for medical products are safe and meet regulatory rules. You will help verify that these designs function correctly and maintain documentation of how they were developed.

The role emphasizes Design Controls, Risk Management, and supporting external testing (EMC/EMI) and keeping verification/validation records, DFMEA/PFMEA. Education: Bachelor’s degree in a scientific or engineering field; electrical engineering is preferred.

Qualifications

• Experience with engineering and development of Class II electro-mechanical medical devices.
• Knowledge of Design Controls and Risk Management practices.
• Supporting medical device compliance testing (EMC/EMI) with external test houses.
• Maintenance of technical design documentation (verification/validation protocols, DFMEA/PFMEA).

Skills

Design Controls

Risk Management

EMC/EMI testing

DFMEA/PFMEA

Documentation

Class II devices

Education

Bachelor’s degree in science or engineering

Job description

Job Summary

The job is for an engineer who makes sure designs for medical products are safe and meet rules. This person helps check that these designs work correctly and keeps records of how they were made.

Must-Have Requirements

• Experience with engineering and development of Class II electro-mechanical medical devices
• Knowledge of Design Controls and Risk Management practices
• Supporting medical device compliance testing (e.g., EMC, EMI) with external test houses
• Maintenance of technical design documentation (e.g., verification/validation protocols, DFMEA/PFMEA)

Preferred Requirements

• Working knowledge of advanced statistical methods using tools like Minitab
• Experience with lasers and optical technologies

Education

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.

Equal Opportunity Employer/Veterans/Disabled

Benefits

• medical
• dental
• vision
• term life insurance
• short-term disability insurance
• additional voluntary benefits
• commuter benefits
• 401K plan
• Paid Sick Leave
• Holiday pay upon meeting eligibility criteria

Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.