Job Title: Senior Staff Design Quality Assurance Engineer
Department: Design Quality Assurance
FLSA Status: Exempt
Position Overview:
Technical Lead for Design Assurance and Quality Engineering activities throughout the Development Lifecycle for new product development and sustaining engineering involving Hardware and Embedded Software Systems for Insulet Corporation. This includes ensuring that the development process is compliant with applicable standards, regulations and guidance documents for medical devices containing Embedded Software. This role will interface with other Insulet departments (e.g. Research and Development, Lifecycle Engineering, Operations, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and services to support our medical devices, partner integrations, and data analytics.
Responsibilities:
- Key member of cross functional development teams supporting development efforts for Hardware and Embedded Software Systems.
- Subject Matter Expert in Design Control to support the development organization. Provide oversight and support for the generation and approval of all Design History File deliverables.
- Subject Matter Expert ensuring compliance to IEC 62304, ISO 14971, 21 CFR 820, and ISO 13485.
- Provide guidance to the development organization on the generation and review of requirements & specifications, design documents, design verification plans, protocols, and reports, traceability matrices and other documentation as required.
- Provide technical expertise to Design Quality Assurance Organization supporting new product development and lifecycle engineering initiatives.
- Support quality related process/product improvement initiatives throughout the Development Lifecycle and DQA activities within the organization to align with industry best practices.
- Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.
Education and Experience:
- ASQ, CSQE or other software quality certificates are beneficial.
- BS degree in an electrical engineering, mechanical engineering, or other engineering or scientific discipline. Master’s degree preferred.
- A minimum of 8 years work experience in Quality within an FDA, ISO, or other regulated environment and/or equivalent combination of education and experience.
- Experience in the development and implementation of effective Design Control Systems for medical devices.
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
- Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and related FDA guidance documents.
- Familiarity with various software development tools (e.g. PLM, configuration management, issue/defect tracking, requirements analysis, etc.).
Skills/Competencies:
- Effective verbal and written communication skills.
- Experience collaborating and communicating with individuals at multiple levels in an 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.
- Ability to influence people and projects in a fast-moving environment.
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). #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $104,325.00 - $156,487.50. 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)
Top Skills
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
