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Senior Staff Mechanical Engineer
| Company | Insulet Corporation |
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| Location | Acton, MA, USA |
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| Salary | $114450 – $171675 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior, Expert or higher |
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Requirements
- A Bachelor of Science or equivalent degree in Mechanical Engineering.
- 10+ years of product development experience and in leading cross functional teams in a regulated industry.
- DFMA, IQ/OQ/PQ, Six Sigma, Lean, DOE skills
- Strong written and verbal communication skills
- Expertise with Solidworks/Pro-E and one of SAS, JMP, or Minitab
- Working knowledge of MS Office, including Office Project software.
Responsibilities
- Advise teams of supplier engineers and quality engineers as they investigate and improve supplier processes, deploy tools and equipment at supplier facilities, and introduce new components to suppliers
- Provide day-to-day mechanical technical leadership to members of the Engineering team by being the subject matter expert on GD&T, principles of mechanical design, and equipment and automation knowledge
- Serve as the key signatory of Insulet component print specifications to ensure that GD&T has been adhered to and that design for manufacturability has been considered
- Lead critical root cause investigations and drive corrective action
- Lead continuous improvement projects, including identifying alternative, more efficient manufacturing methods, deploying automated inspection systems, improving packaging, as well as recommending and implementing component re-designs for manufacturability
- Design gauging and inspection fixtures/equipment in support of Insulet supplier metrology.
Preferred Qualifications
- Master’s degree in engineering
- Development and/or product sustaining environment
- Experience with component design and material selection
- Experience with organized root cause analysis (5 whys, is/is not, Ishikawa, etc)/CAPA
- Experience with formal Risk Management tools including Preliminary Hazard Analysis (PHA), System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA)
- Familiar with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls)
- Experience with projects involving domestic and international regulatory submissions
- Working knowledge of Computer Aided Design & Finite Element Analysis. Advanced knowledge a plus
- Formalized problem solving (Cause and Effect, A3, 5 Whys8Ds, DMAIC, PDCA)
- Ability to present and communicate clearly and confidently to multiple levels of an organization.
- Strong knowledge of Product Development Process, Stage Gate Approach, and Design Control
- Formal project management training (PMP)
- Experience leading organizational change management.
