FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in software quality management, risk assessment, and compliance with regulatory standards such as FDA 21 CFR Part 820 and IEC 62304. Proven ability to lead cross-functional teams and drive continuous improvement initiatives in software development processes.
Highest-signal resume keywords
Software Quality ManagementRisk AssessmentRegulatory ComplianceSoftware Development LifecycleMedical Device Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Software Quality EngineeringRisk Management PrinciplesAgile MethodologyWaterfall MethodologyDevOpsContinuous IntegrationContinuous DeliveryTest AutomationDFMEAPFMEA
Soft Skills
Influencing Organizational DirectionMentoring EngineersExceptional Communication SkillsManaging AmbiguityDriving Complex Programs
Tools & Technologies
ALM SystemsSCM SystemsPLM SystemsCloud TechnologiesDistributed Systems
Industry Keywords
FDA 21 CFR Part 820IEC 62304ISO 13485ISO 14971IEC 82304EU MDRSoftware Lifecycle ComplianceCybersecurity PrinciplesQuality Management SystemsPost-Market Activities
Tech Stack
Tools & technologiesCloudCyber SecurityDistributed SystemsSDLC
About the role
Key responsibilities & impact- Serve as a technical leader and subject matter expert for software quality, risk management, and software lifecycle compliance
- Lead application, compliance, and continuous improvement of software development and V&V processes, including risk management and software design controls for Class I/II exempt applications and components
- Lead complex software quality initiatives spanning multiple products, programs, and functional organizations
- Lead risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues
- Support digital transformation initiatives involving ALM, SCM, and PLM systems supporting the SDLC as defined per IEC 62304
- Provide technical oversight and direction for software risk management activities, including DFMEA, PFMEA, SHA, and hazard analysis
- Review and approve critical quality deliverables, including software lifecycle documentation, risk artifacts, V&V protocols, and design history file content
- Drive organizational improvements related to software quality systems, development practices, automation, verification, validation, and compliance processes
- Evaluate emerging regulations, standards, and industry trends and assess their impact on existing and future products
- Collaborate with senior leadership to define quality strategies supporting business objectives and product roadmaps
- Implement right-sized QMS applications based on software classification per IEC 62304
- Mentor and provide technical leadership to software quality engineers and cross-functional development teams
- Influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations
- Perform other duties as assigned
Requirements
What you’ll need- Typically requires a Bachelor’s Degree in a technical discipline and a minimum of 8–12 years related experience, or Master’s degree and 5–7 years equivalent industry experience, or a PhD and 2–4 years of experience
- Extensive medical device experience
- Demonstrated expertise in FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR, and applicable global regulatory requirements
- Advanced knowledge of software development lifecycle processes and methodologies, including Agile, Waterfall, DevOps, Continuous Integration, Continuous Delivery (CI/CD), and Test Automation
- Deep experience with software quality engineering across requirements, architecture, design, development, testing, release, and post-market activities
- Advanced understanding of software risk management principles, methodologies, and regulatory expectations
- Ability to influence organizational direction and lead cross-functional initiatives without direct authority
- Strong understanding of software architectures, cloud technologies, distributed systems, cybersecurity principles, and data platforms
- Experience supporting regulatory inspections and direct interactions with FDA, notified bodies, and external auditors
- Exceptional written, verbal, and executive-level communication skills
- Ability to manage ambiguity, influence senior stakeholders, and drive complex programs to successful completion
- Demonstrated success mentoring engineers and developing organizational quality capabilities
Benefits
Comp & perks- A full and comprehensive benefits program
- Growth opportunities on a global scale
- Access to career development through in-house learning programs and/or qualified tuition reimbursement
- Home office workplace
- Flex workplace option may be available for employees within commuting distance of a Dexcom site
- 15–25% travel opportunity