Insulet is seeking an Embedded Software Systems Engineer to support the product development phases of their wearable pump technology, focusing on requirements, risk analysis, software design, and defect assessment within an Agile framework.
Requirements
- Demonstrated understanding of Systems Engineering practices such as requirements management and risk analyses.
- Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
- Working knowledge of requirements lifecycle management tools (i.e. Helix ALM, Doors, Arena PLM)
- Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market.
- Experience with root cause analysis
- Experience with software tools and coding (C++)
Responsibilities
- Work with Software Engineers to drive the generation of Software Functional Requirements that meet the higher level Product Requirements as well as the intended goals defined in the product backlog items.
- Lead cross-functional reviews and approval of such Software Functional Requirements.
- Work with the Software Engineering team to document system hazards, failure modes, and risk mitigations.
- Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines.
- Work very closely with Software Engineering, Product Owner, Software QA and other cross functional teams to ensure the appropriate deliverables are available timely to enable the Agile team effective execution.
- Drive other activities such as defect triaging and others as needed
- Drive generation of appropriate deliverables in accordance to FDA and corporate SOPs
Other
- BS in an Engineering (Biomedical, Electrical, Software) discipline preferred
- A minimum of three (3) years’ experience (inclusive of any post-grad work) working on technical design or Systems Engineering in a multidisciplinary project team environment.
- 2+ years of experience in working on technical design
- Domain expertise in one of more associated domains; preferably Software or Electrical Engineering
- Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.
- Ability to communicate at multiple levels of an organization
- Ability to organize and judge priorities in a dynamic environment
- NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days).
- Travel is estimated at 10% but will flex depending on business needs.
