Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
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!
The Senior Software Systems Engineer will be leading and driving the development and analysis of software requirements supporting the software development life cycle of Insulet’s innovation pipeline of wearable medical devices, including cloud and mobile applications.
Responsibilities
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Responsible for the development of software requirements by analyzing user needs and product requirements.
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Lead and drive the technical reviews of software requirements with the required stakeholders from various cross functional teams.
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Create and maintain traceability matrices between requirements, design verification outputs, risk management artifacts, and software design outputs in compliance with FDA guidelines.
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Generate requirement traces and reports as needed for regulatory submissions.
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Manage software requirements and traceability in Insulet’s PLM and ALM tools, including version controlling of the documents.
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Review and consult with Product Owners on user stories that incorporate software requirements, ensuring sufficient detail is provided to guide the Agile development teams.
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Review downstream engineering teams’ development artifacts such as design/architecture documents, design failure mode analysis to ensure implementation meets the specified requirements.
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Review software test deliverables such as test strategy and test cases to ensure alignment with the requirements.
Education and Experience
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Bachelor of Science or equivalent degree in an Engineering (Systems, Biomedical, Electrical, Computer Science) discipline or related engineering/technical degree is required.
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A minimum of five (5) years of experience working on the technical development of medical device products.
Required Skills and Competencies
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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.
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Demonstrated understanding of Systems Engineering practices, such as requirements management, risk analyses, and system and / or software architecture.
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Working knowledge of application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors).
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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.
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Contribute to continuous improvement efforts related to requirements and requirement management tools.
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Experience working in Agile development environments.
Preferred Qualifications
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Formal training in established Systems Engineering concepts.
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Any Formal training or requirement development related certification.
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Knowledge of diabetes management products.
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Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
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Experience with change orders within a Product Lifecycle Management (PLM) tool.
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Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market.
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General understanding of communication, mobile technology, IoT (Internet of Things), GDPR; a strong plus.
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Very detail oriented, ability to work independently with minimal supervision, self-motivated and ability to carry out impact assessment across sub systems.
Required Leadership/Interpersonal Skills & Behaviors
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Ability to effectively manage stakeholders’ expectations and drive team decisions.
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Able to facilitate technical review meetings and explain content to technical and non-technical audience members including but not limited to software, analytics, Site reliability engineers, Cloud Operations, Clinical, Medical, Marketing, Data engineering, Privacy, Regulatory, Product owners, Product Managers.
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Ability to communicate effectively at multiple levels of an organization and provide status reports to management.
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Ability to organize and judge priorities in a dynamic environment. Flexible to change.
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Ability to build and maintain strong working relationships with colleagues in a hybrid and remote work environment with resources spread across different time zones.
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Demonstrated skills with managing multiple tasks, highly adaptive mindset with ability to judge and set priorities.
Additional Information
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The position can be remote within PST or MST time zone, with preference for being located in the San Diego area.
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Travel is estimated at 10%, but will flex depending on business needs.
NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote
Additional Information:
The US base salary range for this full-time position is $101,970.00 - $152,955.00. 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.
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)
What We Do
Insulet Corporation, 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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. 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. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
