Systems Engineer
| Company | Insulet Corporation |
|---|---|
| Location | California, USA, Massachusetts, USA |
| Salary | $79650 – $119475 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level |
Requirements
- BS in Biomedical or Computer Science or any related engineering field
- A minimum of 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 Cloud or Data driven products, with exposure to Software, Quality, and Test Engineering
- Systems Engineering practices such as requirements management, risk analyses, design trade-off and cost-benefit analysis
- 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
Responsibilities
- Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions
- Contribute to system development by defining system, subsystem architecture and design for manufacturing
- Identify and document system hazards, failure modes, and risk mitigations
- Work with the technical centers of excellence domain subject matter experts, and suppliers in the assessment, selection, integration, and qualification of key components and subsystems
- Serve as a technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary
- Oversee engineering evaluations & data analysis reviews
- Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines
- Support the preparation of proposals, program plans, estimates, and present information and status to leadership and other stakeholders
- Drive product investigations, using statistical analysis methodologies
- Contribute to team goals by accomplishing related tasks as required
Preferred Qualifications
- Experience or formal training in established Systems Engineering concepts
- Experience working on data driven products and/or medical data management systems is a huge plus
- Experience working on integrations with Cloud based products and ETLs
- Experience with long term R&D development programs (concept/feasibility, development, commercialization)
- Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS
- 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
- Six sigma training / certification
- Experience with software tools and coding
- Experience with data analysis (Minitab, MatLAB)