Senior Staff Mechanical Engineer (Onsite)

Job Description

The Senior Staff Mechanical Engineer is a key member of Insulet’s Sustaining Engineering team, which is part of Insulet’s Global Manufacturing Engineering Organization. The Mechanical Sustaining engineering team is responsible for driving changes to current-generation Device that improve quality, reduce costs and ensure production requirements. The Senior Staff Mechanical Engineer has several key roles on the team. First, s/he serves as coach and consultant to other Engineers to resolve mechanical challenges that present during component manufacturing and assembly. Second, s/he will own high-value improvement projects. Finally, s/he will serve as a key resource to review and approve component-level print specifications to ensure GD&T is adhered to and that design for manufacturability is considered for all Insulet components.

The Ideal candidate will have significant experience with precision component manufacturing for high-volume assembled devices including precision plastics, metal stampings, screw manufacturing, and packaging design. The ideal candidate additionally has experience working with suppliers of custom precision components for use in medical devices, automotive, or another highly regulated industry.

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

Required Leadership/Interpersonal Skills & Behaviors:

· Provide strong leadership through positive motivation, guidance, and open communication.

· The individual must be able to build the capability of others to assure successful project execution. Engages and energizes others to reach their fullest potential and performance. This can include, but is not limited to improving business process systems, developing training aides and SOPs, and providing effective coaching and feedback to subordinates, peers, and multi-level teams

· Naturally brings groups together to develop action plans and make and document decisions

Required Skills and Competencies:

· Comfortable in a fast-paced environment, and successfully executing against multiple objectives simultaneously

· 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

Education and Experience

Minimum Requirements:

o A Bachelor of Science or equivalent degree in Mechanical Engineering.

o 10+ years of product development experience and in leading cross functional teams in a regulated industry.

Preferred Skills and Competencies:

o Master’s degree in engineering

o Development and/or product sustaining environment

o Experience with component design and material selection

o Experience with organized root cause analysis (5 whys, is/is not, Ishikawa, etc)/CAPA

o Experience with formal Risk Management tools including Preliminary Hazard Analysis (PHA), System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA)

o Familiar with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls)

o Experience with projects involving domestic and international regulatory submissions

o Working knowledge of Computer Aided Design & Finite Element Analysis. Advanced knowledge a plus

o Formalized problem solving (Cause and Effect, A3, 5 Whys8Ds, DMAIC, PDCA)

o Ability to present and communicate clearly and confidently to multiple levels of an organization.

o Strong knowledge of Product Development Process, Stage Gate Approach, and Design Control

o Formal project management training (PMP)

o Experience leading organizational change management.

Additional Information:

· The position is in-pe