Sr Medical Device Engineer

Meet the Team As a key member of Dexcom’s Material Science Center with R&D, you will collaborate with engineers, scientists, and technicians to develop next generation CGM sensor membrane material technologies. This role offers an exciting opportunity for an enthusiastic polymer engineer who understands the technical and regulatory challenges of integrating new materials within the medical device field. You will lead efforts in material development, scale‑up, qualification, and pilot‑scale processing, while partnering cross‑functionally with operations, supply chain, quality assurance, external vendors, and other stakeholders outside of the R&D organization. Where you come in: You will operate polymer synthesis, processing, and analytical testing equipment in support of technical feasibility, development, scaling, and technology transfer initiatives. You will lead qualification activities (IQ/OQ/PQ) of new equipment, facilities, and processes. You will define equipment capabilities and process control limits to assure stable and capable performance within specification limits. You will plan and execute DOE and test protocols that generate rapid insights on processing‑structure relationships to further optimize product design. You will identify and optimize critical formulation and process parameters to deliver robust, capable, and high yielding manufacturing processes. You will develop and validate testing methodologies for process control and finished good QC release testing to ensure product specifications are consistently met. You will collaborate with raw material suppliers, equipment vendors, and other external partners to meet project deliverables and accelerate timelines. You will execute design control deliverables, including documenting laboratory reports, lot history records, manufacturing process instructions, SOPs, inventory and productivity reports, calibration schedules, and preventative maintenance schedules. You will prepare and present technical reports and data‑driven recommendations to stakeholders and leadership. You will train and perform all work in accordance with Dexcom’s quality management system. What makes you successful: You have hands‑on knowledge and experience with polymer synthesis and processing unit operations, ideally within medical device applications. You bring expertise in polymer science or polymer engineering, enabling innovative material solutions. You have practical experience with polyurethane‑based coatings and water‑based dispersions. You have a strong background in equipment, method, and process qualification and validation activities. You have high level of hands‑on mechanical aptitude and can effectively troubleshoot and repair equipment. You are organized, detail oriented, and skilled in problem‑solving, with proficiency in DOE methodology, statistics, data analysis tools (JMP, Python, or MATLAB preferred). You communicate clearly and effectively, both in writing and verbally, and excel as a collaborative problem solver. You have working experience with GLP, GMP and ISO regulations in the context of medical device development and manufacturing. You can lead workstreams, manage timelines, and deliver results in a fast‑paced, dynamic environment. You have the aptitude and creativity to contribute to intellectual property development and innovation initiatives. What you’ll get: A front row seat to life changing CGM technology. 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: 0-5% Experience and Education Requirements: Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Equal Opportunity Employer 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 View email address on click.appcast.io. Accommodations Request 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 View email address on click.appcast.io. Salary $105,800.00 - $176,300.00 #J-18808-Ljbffr Dormont Manufacturing Co