Sr Manager, Design Quality Process Improvement (Hybrid)
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Overview
Job Description
Position Overview:
The Sr Manager, Design Quality Process Improvement, is responsible for leading strategic and results-driven Continuous Improvement initiatives that enhance efficiency, compliance, and innovation across our medical device design and development processes. This role will focus on driving process improvements while aligning with industry standards and collaborating with enterpriseand cross-functional teams to optimize quality systems and product development workflows. In addition, focus on integrating best practices for the Software Development Life Cycle (SDLC) and accelerating efficient execution to enable faster time to market while maintaining compliance with global regulatory standards.
If you’re a quality-focused leader with a passion for continuous improvement and cross-functional collaboration with medical industry experience, this opportunity is for you to drive innovative, efficientand compliant processes.
Responsibilities:
Drive and implement continuous improvement initiatives to optimizeproduct development processesin partnership with cross-functional process owners.
Evaluate and optimizeprocesses to ensure compliance with FDA, ISO 13485, ISO 14971, IEC 62304, and other regulatory standards.
Collaborate with internal standards teams to interpret and implement evolving industry and regulatory standards.
Partner with enterprise and cross-functional teams (R&D, Systems, Regulatory, Quality, Manufacturing, IT) to help drive systems/tools improvement initiatives and help resolve process inefficiencies.
Develop and track key performance indicators (KPIs) to measure the impact and sustainability of improvement initiatives.
Lead change management and training efforts to embed a culture of continuous improvement across the organization.
Support audit and inspection readiness by ensuring robust documentation and traceability of process improvements.
Lead and/or provide robust support for CAPAs as quality partners, ensuring timely investigations, root cause analysis, and effective implementation of corrective actions.
Benchmark internal processes against industry best practices and recommend enhancements.
Champion digital transformation opportunities within design quality systems.
Introduce and implement the best practices for the Software Development Life Cycle (SDLC), including requirements management, design verification, software risk management, and configuration control.
Collaborate with software engineering and quality teams to ensure alignment with IEC 62304 and other relevant software standards.
Drive initiatives that reduce development cycle times and improve execution efficiency without compromising quality or compliance.
Promote a proactive quality culture that supports innovation and accelerates time to market for new products.
Education and Experience:
Bachelor’s degree in engineering, Life Sciences, or related field (master’s preferred)
8+ years of experience in the medical device industry, with strong knowledge of design controls and quality systems.
Proven track record in leading cross-functional continuous improvement projects.
Deep understanding of regulatory standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, etc.).
Experience implementing SDLC best practices in regulated environments.
Lean Six Sigma certification (Green Belt or higher) preferred.
Excellent communication, leadership, program management and stakeholder management skills.
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.
Conflict resolution skills including persuasive management techniques .
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 and requires on-site work from an Insulet office. #LI-Hybrid
Additional Information:
Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $154,100.00 - $231,200.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.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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