Full-Time

Senior Software Design Quality Assurance Engineer

Cloud/Data Products

Confirmed live in the last 24 hours

Insulet Corporation

Insulet Corporation

1,001-5,000 employees

Biotechnology
Healthcare

Compensation Overview

$85.1k - $127.7kAnnually

Senior

Acton, MA, USA + 1 more

More locations: San Diego, CA, USA

Requires on-site work from an Insulet office at least 1x/week; preference for candidates located near San Diego, CA or Acton, MA.

Category
QA & Testing
Quality Assurance

You match the following Insulet Corporation's candidate preferences

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

Degree
Experience
Requirements
  • A minimum of 5 years work experience in Software Quality Engineering within an FDA regulated environment.
  • Degree in engineering/scientific/computer systems or equivalent experience.
Responsibilities
  • Review and approve all cybersecurity related software development artifacts (Cybersecurity Risk Assessments, SBOMs, Penetration Test Report, SAST/DAST Test Reports, etc.) required per design control requirements to meet Design History File requirements. Ensure deliverables comply with regulatory requirements and industry best practices.
  • Ensure compliance with IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
  • Support development teams in the validation of software tools.
  • Support training on cybersecurity design control topics for software development and broader quality organization.
  • Support the creation of necessary documentation to comply with regulatory requirements and industry best practices (SOPs, Templates).
  • Support execution of Cybersecurity Risk Management, for complex systems in compliance with ISO 14971, TIR-57, TIR-97 and related FDA Cybersecurity Guidance documents.
Desired Qualifications
  • Experience with medical device software development
  • Experience with software development lifecycles.
  • Experience in creation and/or maintenance of quality documentation (SOPs, Templates).
  • Experience and knowledge of FDA Quality System Regulations 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, FDA Cybersecurity Guidance documents.
  • Experience utilizing QMS PLM tools.
  • Experience with Non-Product Software Tool validation
  • Familiarity with various software development tools (e.g., configuration management, issue/defect tracking, requirements analysis, etc.)
  • ASQ, CSQE or other software quality certificates is a plus.
  • Masters degree preferred
  • Excellent verbal and written communication skills.
  • Demonstrated ability to collaborate with individuals at multiple levels across the organization.
  • Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
  • Strong analytical and problem-solving skills.
  • Able to work effectively in a high-stress, high-energy environment.

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

-2%
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