Represent Design Assurance organization to support new product development and sustain activities for partner integration products and features
Support partner-focused design quality strategies, ensuring alignment with company goals, industry standards, and regulatory requirements
Ensure shared compliance with global regulations and standards (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 82304) for Class II and III devices
Support design controls, risk management, usability, cybersecurity, and AI/ML validation for interoperable products and systems throughout the product lifecycle
Ensure seamless integration of digital products with partner system components including hardware, firmware, and enterprise platforms
Continuously improve partner-relevant processes to support product excellence in a fast-paced environment
Serve as a subject matter expert on existing partner integrations, providing expertise for pre/post-market risk assessments and support to internal/external design teams
Lead alignment efforts with Insulet QA/RA leadership to resolve emerging partner issues, confirm strategic direction, and deliver consistent messaging to external partners
Maintain partnership quality metrics and key performance indicators, conducting regular reviews and analyses to drive continuous improvement initiatives
Manage the QMS process for inbound/outbound partner communications, assessments, and records retention

Requirements

Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related field; masters degree preferred
8+ years in design quality assurance within the medical device or medical digital health industry, preferably software focused
Experience with medical device / regulated software development lifecycles with emphasis on the software quality engineering aspects
Experience in the development and implementation of effective Design Control Systems
Exposure to quality decision-making, risk management, and quality engineering
Experience with software mobile applications, cloud-based systems, and cybersecurity
Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards
Working knowledge of IEC 62304/82304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for 510(k)
Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.)
ASQ, CSQE or other software quality certificates are beneficial.

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 & Tools

design quality assurancerisk managementusabilitycybersecurityAI/ML validationDesign Control Systemssoftware quality engineeringmedical device development lifecyclecloud-based systemsmobile applications

Soft Skills

leadershipcommunicationcollaborationproblem-solvinganalytical thinkingcontinuous improvementsubject matter expertisestrategic alignmentprocess improvementmetrics analysis

Certifications

Bachelor's degreeMaster's degreeASQ certificationCSQE certification