Sr. Manager, Design Quality Engineering - Product Compliance

Dexcom Inc.; San Diego (CA); Hybrid; USD 142.000 - 236.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits program

Global growth opportunities

Tuition reimbursement

Zusammenfassung

Dexcom Inc. seeks a senior Quality leader for Electrical Safety, EMC and radio certifications across the product lifecycle, based in California with a home-office focus.

You will own global compliance strategies and drive market access for wireless medical devices, coordinating with NRTL and cross-functional partners to ensure robust regulatory success. You will develop surveillance processes, guide lifecycle compliance activities, and lead responses to audits, while collaborating with

Qualifikationen

• Requires a Bachelor’s degree in a technical discipline and 13+ years of industry experience.
• 5-8 years of people management experience.

Aufgaben

• Own global compliance strategy for IEC 60601 Electrical Safety and EMC standards across the CGM product portfolio.
• Lead worldwide radio certification and market access activities for wireless medical devices.
• Engage with NRTL on strategies and provide on-site testing support.
• Drive cross-functional alignment with Regulatory Affairs, R&D, Clinical, Manufacturing and external agencies.
• Represent the organization during regulatory audits and inquiries.

Kenntnisse

Regulatory leadership

NRTL certification

Cross-functional leadership

Communication skills

Regulatory strategy

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

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:

• You will be the accountable Quality leader for Dexcom's Electrical Safety/Electromagnetic Compliance (EMC) and radio certifications across the entire product lifecycle. This includes:
• Own global compliance strategy for IEC 60601 Electrical Safety and EMC standards across the CGM product portfolio, ensuring requirements are effectively integrated throughout the product lifecycle.
• Direct engagement with Nationally Recognized Testing Laboratories (NRTL) on strategies and providing on-site testing support.
• Lead worldwide radio certification and market access activities for wireless medical devices, driving successful approvals and compliance maintenance across global markets.
• Establish and govern external standards surveillance and impact assessment processes, translating evolving regulatory and industry requirements into actionable product and quality system plans.
• Provide quality engineering leadership for lifecycle compliance activities spanning development, commercialization, sustaining engineering, post-market monitoring, and product change management.
• Drive cross-functional alignment with Regulatory Affairs, R&D, Clinical, Manufacturing, and external certification agencies to proactively manage compliance risks and support business objectives.
• 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.
• You will be responsible for leading, organizing, developing, and growing an organization of Compliance Engineers while ensuring required levels of quality engineering support are provided to project teams.
• You will represent the organization during regulatory audits and inquiries.

What makes you successful:

• You 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.
• 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.
• Bachelors degree in Engineering 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:

• 15-25%

Experience and Education Requirements:

• Typically requires a Bachelor’s degree with 13+ years of industry experience
• Requires a degree in a technical discipline
• 5-8 years of previous people management experience

Flex 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].

If 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].

Meritain, 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=true

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:

$141,800.00 - $236,400.00