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 Job
Title: Principal Engineer
Department: Research
and Development
Location: Hopkinton,
Massachusetts, USA
Status: Full-time
Exempt
Job Description: |
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| Principal engineering position focused on new product development
and sustaining engineering programs. Candidate will develop
and execute comprehensive plans, managing project activities
across all internal departments and with external vendors.
Responsibilities include new IP generation, proof-ofconcept
development, CAD design, GD&T print generation, design for
manufacturing, pre clinical test plan development and execution,
implementation of design surgeon feedback, regulatory submission
support (CE, 510(k) and IDE) and maintaining FDA QSR & ISO
13485 design history file requirements. The preferred candidate
will possess a fundamental engineering skill set with thorough
understanding of the orthopedic product development process.
Successful candidates will be able to manage several projects
simultaneously and work in a dynamic environment. |
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| Demonstrated proficiency with Solidworks or equivalent
Successful product launches, preferably in ortho/spine field
Ability to work in and foster a team-based environment Excellent
oral and written communication skills Willingness to travel
Creativity and problem solving skills Adaptability Understanding
of current US and EU compliance requirements Good documentation
practices |
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| Five years orthopaedic product development or equivalent |
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| Educational Requirements: |
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Minimum B.S. Mechanical or Biomedical Engineering
Advanced degree preferred |
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