Manager of Process Engineering at Dexcom

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Apr, 26

Salary

204100.0

Posted On

15 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Process Characterization, Statistical Analysis, Design of Experiments, Lean Manufacturing, Project Management, GMP Operations, FDA Compliance, ISO 13485, Cross-Functional Collaboration, Technical Leadership, Continuous Improvement, Root Cause Analysis, New Product Introduction, Mentoring, Safety Compliance

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: Our Manufacturing Process Engineering team is part of the San Diego Innovation Center of Excellence, driving the development, transfer, and scale-up of manufacturing processes and equipment for new products. In the Pilot Manufacturing environment, we focus on bridging R&D product concepts and full-scale production—developing robust processes, characterizing performance, and ensuring compliance with Design Control requirements. The Process Engineering Manager plays a critical role in leading technical strategy and execution for process development and characterization, enabling successful commercialization of innovative products within a regulated environment. Where you come in: As Process Engineering Manager, you will provide technical leadership to a team of engineers and scientists to: Lead process development, process characterization, and support pilot manufacturing, ensuring processes are robust, well-defined, and compliant with Design Controls, ISO 13485, FDA compliance, and regulatory requirements. Define and oversee Design of Experiments (DOE) to characterize processes, validate changes, and optimize performance using statistical analysis tools (Gauge R&R, Cp/Cpk, SPC). Manage the documentation and execution of experimental requests on pilot manufacturing lines, ensuring proper process controls, traceability, and alignment with product design requirements and Design Development Plans. Monitor pilot line performance, identify trends, and drive improvements through data-driven decision-making and continuous improvement strategies. Interpret build data and process metrics to assess variability, identify root causes, and implement corrective actions using advanced statistical methods. Oversee the transfer and sustaining of processes, test methods, and equipment from development into pilot operations, ensuring product functionality and cost-effectiveness. Collaborate cross-functionally with R&D, Quality, and Operations to align on process specifications, risk management (PFMEA), and validation strategies (IQ, OQ, PQ). Provide hands-on technical guidance for manufacturing workflows, specialized equipment, analytical testing tools, and pilot-scale facilities within a regulated environment. Champion New Product Introduction (NPI) roadmaps and strategies, driving innovation and operational excellence. Select, develop, and mentor engineering talent, fostering a culture of technical rigor and collaboration. Ensure compliance with safety, environmental, and quality standards across all pilot manufacturing activities, supporting regulatory submissions as needed. What makes you successful: The Process Engineering Manager is responsible to maintain proper product functionality, develop and sustain manufacturing processes, and equipment within the San Diego Manufacturing site through: Proven experience managing engineers and scientists, with cross functional disciplines, focused on manufacturing processes, product release testing, and investigations. Knowledge of DMAIC process, structure problem solving, lean manufacturing and project management with proven success of implementation. Proven engineering experience supporting and managing regulated GMP/GLP operations, preferably in medical device, medical diagnostic, and/or pharmaceutical industries. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems). Excellent written and oral skills, driving efficient and effective communication cross functionally. Proven ability to collaborate and drive results in a matrix organization. Recommended to have a STEM degree with proven ability to work hands-on in a fast-pasted environment with competing priorities. 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. Education and Experience: Typically requires a Bachelors degree with 8-12 years of industry experience. 2-5 years of previous management or lead experience. Travel Required: 15-25% 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: $122,500.00 - $204,100.00

Responsibilities

The Process Engineering Manager leads technical strategy and execution for process development and characterization, ensuring successful commercialization of innovative products. This includes overseeing pilot manufacturing processes, managing documentation, and driving continuous improvement initiatives.