Sr Staff Process Development Engineer at Dexcom

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Feb, 26

Salary

225100.0

Posted On

25 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Manufacturing, Quality Compliance, Statistical Analysis, Problem Solving, Collaboration, Leadership, Advanced Technology Integration, Six Sigma, Lean Manufacturing, 3D CAD Software, Process Validation, Root Cause Analysis, Regulatory Compliance, Technical Communication, Mentoring

Industry

Medical Equipment Manufacturing

Description

The Company Dexcom 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 Advanced process engineering team is responsible for the development of processes and manufacturing systems for next-generation products at Dexcom. We are building a world class global R&D capability to support our future innovation, while helping champion the accessibility of sensing technologies. This role offers an individual to lead with purpose and empathy by breaking down the barriers to create a connected, compassionate world. As a Medical Device Process Integration engineer within R&D function you will have an opportunity to lead the development, integration and optimization of advanced manufacturing processes for next-generation products. You will serve as a technical bridge between Advanced technology, R&D and operations developing processes that drive scalability and high-yield solutions. An opportunity within this role is to understand processes from concept to commercialization. This role is critical to ensuring manufacturability, reliability, and regulatory compliance across complex, multi-step high volume processes. Where you come in: Manufacturing Process Development: Architect and implement advanced manufacturing processes, equipment, and fixtures for new products and technologies. Lead design to manufacturing transfers and enable scalable production systems. Process Optimization and Integration: Define, develop, and own complex flows to enhance performance, yield and reliability. Conduct experiments (DOE) and leverage statistical analysis tools to identify areas of improvement and drive down costs. Quality and Regulatory Compliance: Create critical documentation such as Process Failure Mode and Effects Analysis (pFMEA) and control plans. Develop and execute process validation protocols and ensure process meets and adhere to regulatory compliance, including FDA 21 CFR 820, ISO 13485 and EU MDR. Problem Solving: Lead cross-functional teams in root cause investigations and CAPA resolution for high volume systems, driving measurable improvements in yield and reliability. Proactive leadership to resolve process-related issues during development. Collaboration and leadership: Work closely with cross-functional teams, including R&D, Quality, Operations and Regulatory to meet project goals. Communicate technical information and provide expertise to stakeholders, including executive leadership. Advanced Technology Integration: Drive integration of emerging technologies (IoT, robotics, automation) to enable smart manufacturing systems aligned with Dexcom innovation roadmap. What makes you successful: You have an advanced degree (PhD preferred) in Electrical, Mechanical, Biomedical, or Materials Engineering, with deep expertise in process development and Integration You bring proven experience in medical device or high-tech manufacturing, with a proven track record of launching complex products into high-volume production. Proven experience in leading and managing high-performance team is highly desired You are fluent in Six Sigma, lean manufacturing and structured problem-solving methodologies, with a hands-on experience in process validation and statistical analysis tools like JMP. You understand the full product lifecycle - from concept to commercialization - and navigate quality systems and frameworks including FDA QSR, ISO 13485, ISO 14971 and EU MDR with confidence. You communicate with clarity and executive presence, translating technical insights into actionable strategies for diverse stakeholders. You mentor emerging engineers and foster culture of innovation, accountability, and technical excellence. You have strong 3D CAD software (SolidWorks) and process simulation tools, enabling rapid prototyping and scalable design transfer You embrace change and lead with empathy - adapting to evolving needs, championing accessibility, and driving purpose-driven innovation. Strategic Mindset Demonstrates sound judgment and critical thinking in evaluating complex scenarios and making high-quality decisions. Leads change with agility—anticipates future needs, overcomes resistance, and drives alignment across teams. Applies financial acumen to forecast, budget, and assess cost implications of technical decisions. Development & Collaboration Coaches and mentors emerging engineers and leaders through stretch assignments, feedback, and delegation. Communicates with clarity and executive presence—tailoring messages to technical and non-technical audiences. Operational Excellence Solves complex problems with a structured, results-oriented approach; leads CAPA and risk mitigation with decisiveness. Drives cross-functional collaboration to align technical execution with business goals and regulatory requirements. Values & Culture Leads with integrity, empathy, and commitment—modeling emotional intelligence and responsible entrepreneurship. Champions Dexcom's mission to create a connected, compassionate world through accessible sensing technologies. 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: 20% Experience and Education Requirements: Typically requires a Bachelor's degree in a technical discipline, and a minimum of 13+ years related experience or a Master's degree and 8+ years equivalent industry experience of a PhD and 5+ years of experience 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 talentacquisition@dexcom.com. 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 talentacquisition@dexcom.com. 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 To 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. Salary: $135,100.00 - $225,100.00

Responsibilities

Lead the development, integration, and optimization of advanced manufacturing processes for next-generation products. Ensure manufacturability, reliability, and regulatory compliance across complex, multi-step high volume processes.