Staff Product Performance Engineer (Hybrid - Acton, MA)

Insulet Corporation•El Cajon, CA

1d•Hybrid

About The Position

As a Staff Product Performance Engineer at Insulet Corporation, you will play a critical role in supporting our ISO 13485-certified Quality Management System (QMS) within a dynamic and fast-growing medical device environment. Reporting to the Manager of Quality Systems, you will be responsible for leading and managing multiple Corrective and Preventive Actions (CAPAs), with a focus on both product performance and cloud-based software systems. 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
Advanced user skills in Microsoft Word, Excel, and PowerPoint

Nice To Haves

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

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