Description

The Manager, Quality Engineering New Innovation will be a t echnical Lead for Quality activities throughout feasibility for new offer innovation (NOI) development for Insulet Corporation. This includes ensuring that the feasibility process supports innovation by providing guidance and solution options for solving new technology challenges . This role will facilitate a collaborative , innovative environment using Good Laboratory Practices and other best quality practices .

Responsibilities:

• Key member of cross functional NOI team supporting feasibility and innovation efforts

• Subject Matter Expert in new product development with focus on early feasibility

• Provide guidance on applicable regulations and standards (e.g., IEC 62304, ISO 14971, 21 CFR 820, and ISO 13485 )

• Provide guidance to the NOI organization on the generation and review of documentation to support feasibility and initial risks

• Provide technical expertise to the NOI o rganization supporting new product development and lifecycle engineering initiatives.

• Support the creation of necessary documentation to comply with regulatory requirements and industry best practices (SOPs, Templates).

• Support transfer of feasibility activities to design controls , as appropriate

Education and Experience:

• A minimum of 5 years' work experience in a start-up environment or similar working experience that focused on new product innovation

• BS degree in an electrical engineering, mechanical engineering, or other engineering or scientific discipline. Master's degree preferred.

• A minimum of 5 years' work experience in Quality within an FDA, ISO, or other regulated environment and/or equivalent combination of education and experience

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:
The US base salary range for this full-time position is $106,500.00 - $159,750.00. 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.

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.

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