Director HW Design Quality Engineering - New Product Introductions

Dexcom; San Diego (CA); On-site; USD 164,000 - 274,000; Full time

Job summary

Dexcom is seeking a senior Quality leader to drive Design Control, Risk Management and Design Transfer for Advanced Technology and New Product Introduction teams. You will own global Electrical Safety, EMC and Radio certification strategies, while guiding DFSS and other DfX initiatives across platform development.

You will build and lead a team of Design Quality Engineers, partner with cross-functional peers, and represent Dexcom during regulatory audits.

Qualifications

• Bachelor-level engineering degree required.
• Minimum 13 years in medical device development with 8+ years in leadership.
• Strong track record in design controls, risk management, and compliance.

Responsibilities

• Lead as Quality function leader for Dexcom’s Advanced Tech and NPI Core Teams.
• Drive Design Control, Risk Management, and Design Transfer strategies.
• Resolve escalations, make Quality decisions across platforms, and guide cross-functional teams.
• Foster strong partnerships with peers and leaders across the organization.
• Engage in industry standards initiatives, especially Electrical Safety and EMC.
• Lead DFSS and other Design for Excellence initiatives in advanced tech and product development.
• Oversee Electrical Safety, EMC, and Radio certification strategies globally; manage external standards.
• Build and grow a team of Design Quality Engineers and Managers; support platform teams.
• Represent the organization during regulatory audits with clear technical articulation.
• Promote universal understanding and commitment to quality standards and regulatory requirements.

Skills

Design Control leadership

Risk Management

Design Transfer

DFSS

DfX methodologies

Electrical Safety

EMC (IEC 60601-1-2)

Radio Certification

Root Cause Analysis

Project Management (PMBOK/PMP)

Education

Engineering degree

Tools

ISO 14971

IEC 60812

Job description

The CompanyDexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.Meet the team:The Design Quality Engineering (DQE) team at Dexcom is made up of incredibly passionate, collaborative, motivated, and competent people that think big, serve with integrity, and follow through on their commitments without fail. This team takes ownership in driving Design for Excellence (DfX) methodologies across the product lifecycle of Dexcom's on market products and future innovations, as well as leading strategies and supporting outcomes across our Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality system processes.Where you come in: (target 5-8 bullets, max 10)You will be the accountable Quality leader for Dexcom's Advanced Technology and New Product Introduction (NPI) Teams. This includes:Acting as the leader on Dexcom’s Advanced Tech and NPI Core Teams representing the Quality function with an emphasis on deep technical knowledge and end-to-end traceability.Leading Design Control, Risk Management, and Design Transfer strategies and activities that ensure delivery of commitments associated with platform and product development.Resolving escalations, navigating teams to solutions, and acting as the Quality function decision maker for your respective platforms.Fostering strong, positive, supportive, and collaborative partnerships with your cross functional peers and leaders.Engaging directly in industry-wide initiatives around Medical Device standards and guidance- in particular Electrical Safety and EMC.You will act as the Quality lead for Driving Design for Six Sigma (DFSS) and other (DfX) methodologies into advanced technology and product development at Dexcom.You will have strong engagement in technical root cause analysis of issues affecting complex electro-mechanical and chemical systems.You will also have ownership of Electrical Safety, Electromagnetic Compliance, and Radio certification strategies globally, as well as ownership of external standards management at Dexcom.You will be responsible for leading, organizing, developing, and growing an organization of Design Quality Engineers and Managers while ensuring required levels of quality engineering support are provided to Platform teams.You will represent the organization during regulatory audits and inquiries, clearly articulating technical details of product design, design controls, risk management, and statistics as applicable.You will promote cross-functional understanding and commitment to quality standards, quality processes, and regulatory requirements.What makes you successful:Product Development Design Control strategic leadership experienceProduct Development Risk Management (ISO 14971 and IEC 60812) strategic leadership experienceStrong Project Management Experience (PMBOK/PMP)Design for Six Sigma (DFSS) and other Design for Excellence (DfX) methodologies strategic leadership experienceTechnical Root Cause Analysis methodology strategic leadership experienceStatistics Program Development expertiseBiocompatibility expertiseElectrical Safety, Electromagnetic Compliance (IEC 60601-1-2), and Radio Certification expertiseYou have demonstrated leadership experience in working with NRTL’s on certification strategies for medical devices as well as local regulatory authorities globally regarding earning radio certifications.Mechanical and Electrical Systems Engineering expertiseRegulatory Inspections and Audits expertisePeople leadership, team development, and organizational design experienceYou must have a minimum of 13 years of experience in medical device development.You bring at least 8 years in progressively responsible leadership roles.You demonstrate an ability to adapt to shifting priorities and manage multiple initiatives.You possess exceptional interpersonal, written, and verbal communication skills.You are self-motivated with a collaborative, proactive, and accountable approach.Engineering degree preferred.What you’ll get:A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community .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.An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.Travel Required:5-15%Experience and Education Requirements:Typically requires a Bachelor’s degree with 15+ years of industry experienceRequires a degree in a technical discipline9+ years of successful management experience in relevant industryFlex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail] you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail], an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=trueTo all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.Salary:$164,200.00 - $273,600.00#DexcomUS