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Senior Software Systems Engineer
| Company | Insulet Corporation |
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| Location | San Diego, CA, USA |
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| Salary | $109800 – $164700 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor of Science or equivalent degree in an Engineering (Systems, Biomedical, Electrical, Computer Science) discipline or related engineering/technical degree required.
- Five (5) years of experience working on the technical development of medical device products.
- Highly skilled in requirements writing and analysis for functional and non-functional software requirements, documentation and traceability, including system and / or software requirements, for complex systems in a multidisciplinary team environment.
- Demonstrated understanding of Systems Engineering practices, such as requirements management, risk analyses, and system and / or software architecture.
- Working knowledge of application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors).
- Excellent project team and collaboration skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, including software developers, systems engineers, Product Owners, and design quality experts.
- Experience working in Agile development environments.
Responsibilities
- Responsible for the development of software requirements by analyzing user needs and product requirements.
- Lead and drive the technical reviews of software requirements with the required stakeholders from various cross functional teams.
- Create and maintain traceability matrices between requirements, design verification outputs, risk management artifacts, and software design outputs in compliance with FDA guidelines.
- Generate requirement traces and reports as needed for regulatory submissions.
- Manage software requirements and traceability in Insulet’s PLM and ALM tools, including version controlling of the documents.
- Review and consult with Product Owners on user stories that incorporate software requirements, ensuring sufficient detail is provided to guide the Agile development teams.
- Review downstream engineering teams’ development artifacts such as design/architecture documents, design failure mode analysis to ensure implementation meets the specified requirements.
- Review software test deliverables such as test strategy and test cases to ensure alignment with the requirements.
Preferred Qualifications
- Formal training in established Systems Engineering concepts.
- Any Formal training or requirement development related certification.
- Knowledge of diabetes management products.
- Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
- Experience with change orders within a Product Lifecycle Management (PLM) tool.
- Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market.
- General understanding of communication, mobile technology, IoT (Internet of Things), GDPR; a strong plus.
