Full-Time

Senior Software Systems Engineer

Confirmed live in the last 24 hours

Insulet Corporation

Insulet Corporation

1,001-5,000 employees

Biotechnology
Healthcare

Compensation Overview

$109.8k - $164.7kAnnually

Senior

Acton, MA, USA + 1 more

More locations: San Diego, CA, USA

Position requires availability to go into the San Diego office as needed.

Category
Backend Engineering
Mobile Engineering
Software Engineering

You match the following Insulet Corporation's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Bachelor of Science or equivalent degree in an Engineering (Systems, Biomedical, Electrical, Computer Science) discipline or related engineering/technical degree is required.
  • A minimum of 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.
Desired 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.

Company Stage

IPO

Total Funding

$134.6M

Headquarters

Acton, Massachusetts

Founded

2000

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

-1%

2 year growth

-1%
Simplify Jobs

Simplify's Take

What believers are saying

  • Omnipod 5's expansion in Europe boosts Insulet's international market presence.
  • New manufacturing facility in Malaysia supports increased production capacity and job creation.
  • Growing global insulin pump market offers significant revenue opportunities for Insulet.

What critics are saying

  • Emerging competitors like Tandem Diabetes Care threaten Insulet's market share.
  • Geopolitical tensions in Malaysia could disrupt Insulet's supply chain.
  • Technical challenges with sensor integration may delay Omnipod 5 product rollouts.

What makes Insulet Corporation unique

  • Insulet's Omnipod 5 offers tubeless insulin delivery, a unique market feature.
  • Integration with Dexcom G7 and FreeStyle Libre 2 Plus enhances Omnipod 5's functionality.
  • Insulet's proprietary technology is protected by a recent $452 million trade secret victory.

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Benefits

Remote Work Options