Staff Automation Process Engineer at Dexcom

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Feb, 26

Salary

185100.0

Posted On

07 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation Methodologies, Statistical Methods, Data Analysis, Risk Management, Problem-Solving, Communication, Collaboration, Stakeholder Management, Continuous Improvement, LEAN, Six Sigma, CAD, SolidWorks, Validation Systems, Minitab, JMP

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: You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies spanning our suppliers, contract manufactures and automation houses. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for the qualification, validation and change management of complex manufacturing automation equipment, working closely in cross-functional teams to integrate cutting-edge technology into our manufacturing processes. You will ensure high efficiency, precision, and quality in our operations. You will play a pivotal role in ensuring robust new product introduction, capacity expansions, and sustained on-market performance. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle. Where you come in: You will lead validation strategy, execution, and compliance for manufacturing processes, equipment, and technologies across Dexcom's global manufacturing sites, including New Generation Sensor programs. You will develop validation master plans and protocols (IQ/OQ/PQ) and oversee execution to ensure compliance with applicable standards. You will support equipment optimization, modernization projects, and continuous improvement initiatives across global sites to enhance performance, reliability, and scalability. You will analyze validation results and drive continuous improvement and risk mitigation. You will collaborate with R&D, Quality, Regulatory, and Manufacturing to integrate validation into the product lifecycle and manufacturing readiness. You will partner with global engineering, operations, and suppliers to harmonize validation methodologies and share best practices worldwide. You will provide subject matter expertise (SME) in validation and share best practices with peers and cross-functional teams. What makes you successful: You have deep expertise in validation methodologies (IQ/OQ/PQ, process validation, CSV, CSA) with a strong track record of leading compliant validation activities. You bring proficiency in statistical methods, data analysis, and risk management tools (DOE, SPC, FMEA, PFMEA). You have experience leading validation programs across multi-site/global operations in a regulated industry. You are highly detail-oriented, data-driven, and skilled in problem-solving, with the ability to thrive in complex and fast-paced environments. You have excellent communication, collaboration, and stakeholder management skills, and can influence across functions. You are adaptable and able to manage ambiguity while maintaining focus on results. Your proficiency in CAD (SolidWorks), validation systems (ValGenesis), or certifications such as PMP or Six Sigma is a nice to have. Key Competencies: Expertise (7-10 years experience) in regulatory requirements and standards such as FDA 21 CFR Part 11, and ISO standards. This includes the ability to develop and execute validation protocols (IQ/OQ/PQ) to ensure compliance. Bachelor's degree in mechanical, Biomedical or related engineering discipline with a strong focus on medical device manufacturing, automated systems and process technologies. Possesses hands-on experience with high volume automation assembly machines from development to qualification through to on-market continuous improvement and change management. Experience in statistical process control (SPC) and use of software tools such as Minitab or JMP for data analysis, process troubleshooting and optimization. Demonstrated success in driving continuous improvement initiatives using LEAN, KAIZEN, and Six Sigma methodologies to significantly enhance equipment efficiency, reduce operational costs, and elevate product quality standards. What you'll get: (this section should not be modified) 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. 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: $111,100.00 - $185,100.00

Responsibilities

Lead validation strategy, execution, and compliance for manufacturing processes and technologies across global manufacturing sites. Collaborate with cross-functional teams to integrate validation into the product lifecycle and ensure high efficiency and quality in operations.