Design Quality Engineer - ZipRecruiter : Job Details

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

Job Title: Design Quality Engineer

Location: Westford, MA

Start Date: ASAP

Duration: Contract

Compensation Range: $35-40 Per Hour W2

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

• Document review under risk management
• Performing CAPAs
• Change management including manufacturing process modifications and end-of-life product replacements, document reviews, and change requests
• Interacting with R&D
• Identifying qualification work and end-of-life issues
• Conducting FMEAs for medical devices
• Sustaining design and addressing end-of-life issues

• 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 changes
• Six Sigma certification and problem-solving skills
• Hands-on experience with design verification and validation (V&V)
• Understanding of IQ, OQ, PQ protocols
• Risk management experience, including FMEAs and design feedback loops
• Familiarity with design history files and design change identification
• Ability to assess design standards and integrity
• Strong documentation and investigative skills, with eagerness to learn

• Green Belt certification
• Additional risk management experience