Staff Product Performance Engineer
Diabetes Youth Families
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $112,425 - $168,637 per year
Job Level
Lead
Tech Stack
Cloud
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CAPA managementSystems EngineeringRoot Cause Investigationrequirements managementdesign trade-off analysiscost-benefit analysishazards assessmentsrisk assessmentsQMS compliancequality system development
Soft skills
leadershipmentoringcollaborationteamworkflexibilityproject managementcommunicationproblem-solvingorganizational skillsinterpersonal skills