Design Quality Engineer

ZipRecruiter; Westford (MA); On-site; USD 100,000 - 125,000; Full time

Job summary

A leading company is seeking a Design Quality Engineer in Westford, MA for a long-term contract role. The engineer will engage in documentation reviews, CAPAs, and manage change processes while ensuring compliance with design controls in medical devices. This position requires at least 2 years of experience and knowledge in design verification and risk management.

Benefits

Health insurance

Retirement plans

Paid sick leave

Qualifications

• At least 2 years of experience in medical device design.
• Knowledge of design controls and external standards (e.g., EUMDR).
• Familiar with design history files and design integrity assessments.

Responsibilities

• Review documents related to risk management.
• Perform CAPAs and manage change processes.
• Conduct FMEAs for medical devices.

Skills

Problem-solving

Documentation skills

Investigative skills

Design controls knowledge

Risk management

Job description

Job Description

Apply now: Design Quality Engineer, located in Westford, MA. The start date is ASAP for this long-term contract position.

Job Title: Design Quality Engineer

Location: Westford, MA

Start Date: ASAP

Duration: Contract

Compensation Range: $35-40 Per Hour W2

• The above estimate reflects the typical compensation range at the time of hire. Factors such as experience and skillsets may influence the actual hourly rate. Candidates usually start at the lower end of this range.
• This role is eligible for Mondo's health insurance and retirement plans. Paid sick leave eligibility is subject to applicable state or local law.

Day-to-Day Responsibilities:

• Document review related to risk management
• Performing CAPAs
• Managing change processes, including manufacturing process updates and end-of-life product replacements, involving document reviews and change requests
• Interacting with R&D teams
• Identifying qualification work and end-of-life issues
• Conducting FMEAs for medical devices
• Sustaining design efforts related to end-of-life issues

Must Haves:

• At least 2 years of experience in medical device design
• Knowledge of design controls and external standards (e.g., EUMDR)
• Experience with CAPAs, resolution plans, and standards updates
• Six Sigma certification and problem-solving skills
• Hands-on experience with design verification and validation (V&V), IQ/OQ/PQ
• Risk management experience, including design FMEAs and change management
• Familiarity with design history files and design integrity assessments
• Strong documentation and investigative skills, with a willingness to learn

Nice to Haves:

• Green Belt certification
• Additional risk management experience