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Job Requirements of Design Engineer:
-
Employment Type:
Contractor
-
Location:
West Point, PA (Onsite)
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Design Engineer
Careers Integrated Resources Inc
West Point, PA (Onsite)
Contractor
Job Title: Design Engineer
Location: West Point, PA
Duration: 12+ Months
Job Description:
Qualifications:
Education:
Preferred skillsets:
Location: West Point, PA
Duration: 12+ Months
Job Description:
- The basic function of this position is to author technical change assessments related to medical devices and to provide support to customer complaints including ensuring the root cause appropriately considers the device and device constituents, author technical and risk assessments related to the device design change and document the device risk analysis from complaints.
- Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and devices.
- The candidate will work with a small team that supports life-cycle management activities of medical device combination products.
- Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
- Proven problem-solving abilities.
- Demonstrated written and verbal communication skills.
Qualifications:
Education:
- Bachelors in Science, Engineering or related field.
- Can be a mix of Co-op and real-world experience (3-5+ years).
- Has experience in authoring design control documentations per 21 CFR 820.30 or device risk document per ISO 14971.
- Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
- Proven analytical abilities. Work requires experience in engineering change assessment, root cause investigations and device risk document management.
Preferred skillsets:
- Medical device combination product background/experience, understanding root cause, deviation management and change management.
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