Senior Project Engineering Administrator, R&D (Remote/Flexible)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Job Title:                             Senior Project Engineering Administrator, R&D

Department:               R&D

FLSA Status:                      Exempt

Position Overview:

The Senior Project Engineering Administrator, R&D will support, and coordinate R&D project responsibilities related to design and development of Insulet’s products.  This position entails the harmonization of product structures within Insulet’s Product Lifecycle Management (PLM) system and the management and generation of Design History File (DHF) documentation across new product development and Lifecycle Engineering (LCE).

Responsibilities:

• Coordinate across Engineering project teams across R&D and document control functions to prepare, review and expedite Engineering/Document Change Orders by applying knowledge of technical documentation & product structures.
• Manage and define structure for R&D documentation within a PLM System. Includes, but not limited to Device Master Records, bill of materials (BoM), labeling specs, mechanical specification drawings, assembly drawings, etc.
• Collaborate directly with Design Quality Assurance teams ensuring traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.
• Serve as the R&D liaison and advisor for PLM change order processes
• Collaborate with document control to identify and drive efficiency improvements within the PLM change mgt tool
• Collaborate directly with Engineering disciplines to transfer various DHF artifacts from Application lifecycle management (ALM) tools into PLM (QMS repository). Includes, but not limited to design input requirements, design verification results and tracing.
• Support creation and approval of part approval plans (PAPs) for new components and/or suppliers
• Support R&D technicians in configuration control and documentation filing for design verification and development and clinical samples.    
• Perform other administration duties as required.

Education and Experience:

Minimum Requirements:

• Two (2) years of higher education or equivalent in a technical/engineering background
• A minimum of 7 years’ experience managing product structures within a PLM system
• A minimum of 7 years’ experience working in a multidisciplinary product development environment
• Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs but adaptive to address business and market needs.
• Demonstrated expertise in product development and commercialization activities related to Design Controls and Product Lifecycle Management.
• Excellent management skills; experience and capability managing collaboration under a Quality Management System (QMS), as part of a cross-functional team that includes development/verification/validation/procurement/manufacturing/regulatory and quality experts.

Preferred Skills and Competencies:       

• B.S. or equivalent degree in an Engineering/technical discipline
• Demonstrated skills in commercialization of FDA regulated medical devices (Class 1, 2 or 3) using design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Demonstrated success in managing programs/projects involving multiple disciplines from development through commercialization

Physical Requirements (if applicable):  

• This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired)

Additional Information: