Manager, Quality Engineering New Innovation (onsite)

Manager, Quality Engineering New Innovation

The Manager, Quality Engineering New Innovation will be a technical 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 organization 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).