Staff Product Performance Engineer

Job not on LinkedIn

Yesterday

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $112.4k - $168.6k / year

⏰ Full Time

🔴 Lead

👷🏻‍♀️ Engineer

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Diabetes Youth Families

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Healthcare Insurance • Hardware

Diabetes Youth Families is a company that provides wearable insulin delivery solutions for diabetes management. Their primary products, such as the Omnipod 5 and Omnipod DASH systems, offer tubeless and automated insulin delivery for people with Type 1 and Type 2 diabetes, allowing users to manage their condition without the need for multiple daily injections. The systems integrate with continuous glucose monitoring (CGM) devices and can be controlled via compatible smartphones, enhancing the freedom and lifestyle of individuals living with diabetes. With a focus on reducing the burden of diabetes management, they offer financial assistance, support resources, and trial programs to help users adapt to their innovative solutions. The company emphasizes making life simpler while managing diabetes through technology-driven insulin management systems.

11 - 50 employees

Founded 1938

⚕️ Healthcare Insurance

🔧 Hardware

📋 Description

• 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 Director, 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