Job Summary
Position Overview:This position is responsible for Design Control to ensure current products and new projects meet the regulatory and quality requirements for medical devices. Interfaces with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. Effectively communicate design and development regulations, optimizing development, review and/or approval of design documents and protocols and ensuring ambiguities and conflicting requirements are resolved are critical to the success of the position.
Position Overview:
This position is responsible for Design Control to ensure current products and new projects meet the regulatory and quality requirements for medical devices. Interfaces with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. Effectively communicate design and development regulations, optimizing development, review and/or approval of design documents and protocols and ensuring ambiguities and conflicting requirements are resolved are critical to the success of the position.
Responsibilities:
• Responsible for Design Control initiatives to develop appropriate Design History File documents. Review and approve new product documentation, as required.
• Collaborate with Project Management to optimize Design Control process and develop Sustaining Quality Engineering process.
• Review and approve Design Control documents and protocols.
• Serve as the Design Control expert to organization.
• Develop and deliver Design control training for organization.
• Support CAPA activities
• Support Risk Management activities and ensure compliance to standards and regulation
• Performs other duties as assigned.
Education and Experience:
Minimum Requirements:
• BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience.
• A minimum of 2-5 years work experience in Quality Assurance 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.
• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices.
• Working knowledge of EN 60601, Safety requirements for medical electrical systems.
• Working knowledge of ISO 62304, Medical Device Software – Software Life Cycle Process
• Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).
• Demonstrated experience organizing and maintaining large documentation sets.
• Ability to follow up with task owners to close out open items.
• Familiarity with structured phase-gate product development processes.
• Familiarity with FDA, ISO, and other international regulatory requirements.
Preferred Skills and Competencies:
• Effective verbal and written communication skills.
• Experience collaborating and communicate with individuals at multiple levels in an organization.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Skilled in computer use including word processing, spreadsheet, and database applications.
• Able to work effectively in a high-stress, high-energy environment.
Physical Requirements:
• Travel as required to support business needs
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!
Skills Required
- BS degree in engineering, scientific, computer systems, or quality management or equivalent experience.
- 2-5 years of Quality Assurance experience in an FDA, ISO or other regulated environment.
- Experience developing and implementing effective Design Control systems.
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820).
- Working knowledge of ISO 13485 (Medical devices - Quality management systems).
- Working knowledge of ISO 14971 (Application of risk management to medical devices).
- Working knowledge of EN 60601 (Safety requirements for medical electrical systems).
- Working knowledge of ISO 62304 (Medical Device Software - Software Life Cycle Process).
- Fluent computer skills and proficiency with Microsoft Office (Word, Excel, Access, PowerPoint).
- Demonstrated experience organizing and maintaining large documentation sets.
- Ability to follow up with task owners to close out open items.
- Familiarity with structured phase-gate product development processes.
- Familiarity with FDA, ISO, and other international regulatory requirements.
- Travel as required to support business needs.
- Effective verbal and written communication skills.
- Experience collaborating and communicating with individuals at multiple organizational levels.
- Ability to organize and judge priorities and generate/maintain accurate records.
Insulet Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Insulet and has not been reviewed or approved by Insulet.
-
Healthcare Strength — Healthcare coverage is broad, including medical, dental, vision, life and disability insurance, wellness resources, and an EAP. Plan details are described as comprehensive, with PPO options and first-day eligibility noted in some cases.
-
Retirement Support — Retirement programs include a 401(k) with a company match equal to 50% of the first 6% of pay, with vesting after a year. This match is paired with other financial benefits and is characterized as a strong element of the package.
-
Equity Value & Accessibility — An ESPP with a 15% discount and a look-back enables stock purchases at 85% of the lower offering-period price. This feature is presented as a notably attractive wealth-building benefit.
Insulet Insights
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
