Principal Process Development Engineer

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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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 a team that leads endtoend technical oversight across external suppliers contract manufacturers and specialized automation partners for our wet chemistries electronics and hardware systems. You will play a lead role in translating novel materials chemistries and polymer systems into robust scalable manufacturing solutions for new product introductions (NPI) onmarket changes and sustained performance across the Dexcom portfolio. You will collaborate closely across R&D Quality Regulatory Supply Chain and Manufacturing gaining broad exposure across the full product lifecycle from advance tech development through commercialization.

Where you come in:

• You will support a range of programs from new product introductions and launches to scale up on-market and end of life management. Leading collaborative efforts and directing material selection activities ensuring seamless progression timely feedback and optimization while fostering teamwork and accountability.

• Anticipate and respond to changing market requirements by positioning the business to proactively address emerging regulatory and stainability trends and market shifts; maintained business continuity customer satisfaction and competitive margin profile/performance differentiation.

Preparation

• Establish manufacturing readiness plans for chemical and polymer unit operations and associated inprocess controls align process requirements materials specifications and analytical test strategies ahead of transfer.

• Define process performance targets and critical quality attributes and process parameters using firstprinciples materials science and structured experimentation DOEs supported by statistical methods.

Manufacturing Transfer

• Lead technology transfer from R&D to Operations including development of process flow maps and control strategies coordinate equipment user requirement documents with robust validation to meet cGMP/FDA/ISO requirements.

• Partner with Analytical Development/Quality to transfer and validate analytical and assay methods into QC environments including robust test method development and validation.

• Drive materials selection and supplier process qualification ensuring material lots and supply chain are compatible with scaleup and compliance requirements to support sustained robust global manufacturing.

Scale

• Architect scaleup roadmaps from lab/pilot to highvolume manufacturing balancing process physics materials behavior (structureprocessingproperty relationships) and production constraints. Implement data pipelines for capability monitoring and continuous improvement.

• Lead rootcause investigations and failure analysis across materialprocessproduct interactions. Then deploy corrective/preventive actions that harden process robustness and product reliability.

• Provide technical leadership to internal teams and external manufacturing partners.

What makes you successful:

• Recognized subject matter expertise in chemical and polymer systems with demonstrated mastery of structureprocessingproperty relationships and their application to high volume highly regulated medical device/diagnostics manufacturing.

• Proven leadership of technology transfer programs spanning process design validation and analytical method transfer; comfortable navigating device/diagnostic cGMP FDA and ISO environments.

• You have will have a track record of cross functional influence from executive level communication to coaching engineers. Bring clarity in ambiguity and driving decisions that integrate business strategy with technical depth.

• You stay abreast of advancing technologies and processes and the competitive landscape proactively seeking out opportunities for implementation.

• You will closely engage with cross-functional partners in manufacturing R&D supply chain and quality assurance.

• You drive innovation in approach processes and methodologies while ensuring adherence to company customer and industry requirements and specifications. This includes offering recommendations for technology and process solutions to enhance performance and achieve both short-term and long-term objectives.

• You engage in an environment of personal and team accountability that is conducive the development and growth of the team through mentoring and coaching.

Key Competencies:

• PhD or MS in Chemical Engineering Materials/Polymer Science Analytical Chemistry Pharmaceutical Sciences or related field (PhD Preferred).

• Diagnostics/pharma/biotech experience especially in analytical development and method transfer supporting device/assay workflows.

• Demonstrated success in NPI and manufacturing scaleup for chemical/polymer processes including validation to cGMP and ISO standards; familiarity with combination product interfaces is a plus.

• Proficiency with Six Sigma/Lean statistical tools and manufacturing execution documentation (pFMEA control plans sampling plans).

What youll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.

• A full and comprehensive benefits program.

• 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:

• 25 to 50%

Experience and Education Requirements:

• Typically requires a Bachelors degreein atechnical discipline and a minimum of15 years related experience or aMasters degree and 10 yearsequivalent industry experience or a PhDand 7 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. Dexcoms AAP may be viewed upon request by contacting Talent Acquisition at

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

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: 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: