Insulet Corporation · 4 months ago
Sr Manager, Design Quality Assurance - Continuous Improvement
US - California (San Diego - Office)
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $225K/yr
8+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Sr. Manager, Design Quality Assurance – Continuous Improvement, will lead strategic initiatives to enhance efficiency and compliance in medical device design and development processes, while collaborating with cross-functional teams to optimize quality systems.
Health CareMedicalMedical Device
Responsibilities
Drive and implement continuous improvement initiatives to optimize product development processes in partnership with cross-functional process owners
Evaluate and optimize processes 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
Qualification
Required
Bachelor's degree in engineering, Life Sciences, or related field
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
Excellent communication, leadership, program management and stakeholder management skills
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
Strong analytical and problem-solving skills
Ability to influence people and projects in a fast-moving environment
Preferred
Master's degree
Lean Six Sigma certification (Green Belt or higher)
Company
Insulet Corporation
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.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase