Project Engineer
Danvers, MA, 01923
Apply now: Project Engineer, Sustaining Engineering, location is Hybrid in Danvers, MA. The start date is ASAP for this 6 month contract position with potential to extend.
Job Title: Project Engineer, Sustaining Engineering
Location-Type: Hybrid – 3 days onsite in Danvers, MA
Start Date Is: ASAP
Duration: 6 month contract with potential to extend (not contract-to-hire)
Compensation Range: $50-$55/hour W2
Benefits: Eligible for Health, Dental, Vision, 401K
Must be authorized to work in the U.S. This position is not eligible for sponsorship.
Job Description:
Seeking a hands-on Project Engineer to support sustaining engineering activities for a regulated medical device system, focusing on CAPA execution, component obsolescence management, and technical documentation.
Responsibilities:
- Own and drive CAPAs from investigation through closure.
- Lead component obsolescence programs, including assessing, qualifying, and implementing replacement components.
- Develop technical reports, investigations, change justifications, and verification/validation documentation.
- Collaborate with Quality, Manufacturing, Supply Chain, and Regulatory teams to gain alignment on engineering changes.
- Support ongoing sustaining engineering initiatives, ensuring timely execution and accurate documentation.
- Independently manage technical projects involving product changes and compliance requirements.
Minimum Requirements:
- Bachelor's degree in Engineering (Biomedical, Electrical, or Mechanical preferred).
- Experience in sustaining engineering, CAPA, post-market engineering, or design changes within a regulated environment.
- Strong technical writing and documentation skills.
- Experience investigating technical issues and supporting engineering change processes.
- Ability to work independently on detail-oriented technical projects.
Preferred Qualifications:
- Medical device industry experience.
- Experience with capital equipment or electromechanical devices.
- Familiarity with component obsolescence and end-of-life replacement programs.
- Experience with verification and validation activities.
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