Insulet Corporation · 1 day ago
Staff Product Performance Engineer (Hybrid - Acton, MA)
Acton, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$112K/yr - $169K/yr
7+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions. As a Staff Product Performance Engineer, you will support the Quality Management System and lead multiple Corrective and Preventive Actions (CAPAs) focusing on product performance and cloud-based software systems.
Health CareMedicalMedical Device
Responsibilities
Responsible for managing, leading, and completing Product and Cloud Software CAPA phases effectively and on time from issue identification to resolution and verification of effectiveness
Partner with Product Software, Cloud Software, Product Owners, and Software Quality Assurance teams to ensure CAPA deadlines are met
Work with CAPA Process Owner to ensure Product and Cloud Software CAPAs are managed efficiently and effectively
Mentor other CAPA owners on the execution of CAPAs
May be responsible for planning and tracking CAPA performance against key performance indicators (KPIs)
Assist in the development, implementation and maintenance of the quality system and its procedures
In conjunction with the Quality Systems team, maintain QMS compliance with Medical Device Single Audit Program and ISO 13485
Suggest methods for and improve quality system effectiveness, with emphasis on preventive action
Qualification
Required
Bachelor of Science or equivalent degree
7+ Experience working as a Hardware, Software Systems Engineer or with Systems Engineering responsibilities in a multidisciplinary project team environment
Demonstrated expertise in leading CAPAs
Experience in leading a cross-functional development team is preferred
Domain expertise in one or more associated domains; preferably Systems or Software Engineering, with exposure to Mechanical, Quality, and Test Engineering
Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
Demonstrated expertise in Root Cause Investigation techniques such as 5-Whys, Fishbone, Is/Is not, etc
Demonstrated knowledge of and experience with the application of 21CFR820 and ISO 13485
Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes software development, software testing, cloud, quality design assurance, regulatory and quality experts
Knowledgeable of product development lifecycle, including software and or disposable development
Ability to foster teamwork to work cooperatively and effectively with team members
Demonstrated flexibility and ability to function in a fast-paced, growth industry and work environment
Preferred
Initiative to identify opportunities for improvements
Interpersonal skills to promote and accomplish constructive solutions to problems
High level of attention to detail and accuracy
Excellent organizational, problem-solving and communication skills
Ability to prioritize work and handle multiple assignments, while maintaining quality
Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
Ability to work effectively between multiple levels within the organization
Advanced user skills in Microsoft Word, Excel, and PowerPoint
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
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