Hybrid Staff Product Performance Engineer

at Diabetes Youth Families

• Job title: Staff Product Performance Engineer
• Job type: Full Time
• Experience level: Lead
• Salary: $112,425 - $168,637 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Cloud
• Location requirements: Hybrid, Acton, United States

About the role

• Staff Product Performance Engineer managing CAPA for Insulet’s quality management in medical devices. Leading cross-functional collaboration and ensuring ISO compliance in a dynamic industry.

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

Requirements

• 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

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs