Position Overview

This position is responsible for supporting Quality Assurance and Quality Engineering activities related to Product Cybersecurity throughout the Software Development Lifecycle for new product development and sustaining product development initiatives, including cloud and mobile apps. The activities include ensuring that the software development process is compliant with applicable domestic and international cybersecurity standards, regulations and guidance documents for medical devices, SaMD, and cloud, and incorporating secure software development lifecycle (SDLC) principles into Insulet procedures. This role will interface with other Insulet departments (e.g., Research and Development, Product Security, Sustaining, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to integrated cybersecurity product development.

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.

Minimum 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.

Preferred Skills And Competencies

• 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.

Requirements

Physical Requirements

The position is eligible for hybrid working arrangements, preference for candidates located near San Diego, CA or Acton, MA. Limited travel (1x per year) may be required.

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).

Additional Information

The US base salary range for this full-time position is $85,125.00 - $127,687.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran...(Know Your Rights)