Sr Medical Device Engineer

Dexcom • San Diego, CA

2d

About The Position

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: 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.

Requirements

• Hands-on knowledge and experience with polymer synthesis and processing unit operations, ideally within medical device applications.
• Expertise in polymer science or polymer engineering, enabling innovative material solutions.
• Practical experience with polyurethane-based coatings and water-based dispersions.
• Strong background in equipment, method, and process qualification and validation activities.
• High level of hands-on mechanical aptitude and can effectively troubleshoot and repair equipment.
• Organized, detail oriented, and skilled in problem-solving, with proficiency in DOE methodology, statistics, data analysis tools (JMP, Python, or MATLAB preferred).
• Communicate clearly and effectively, both in writing and verbally, and excel as a collaborative problem solver.
• Working experience with GLP, GMP and ISO regulations in the context of medical device development and manufacturing.
• Lead workstreams, manage timelines, and deliver results in a fast-paced, dynamic environment.
• Aptitude and creativity to contribute to intellectual property development and innovation initiatives.
• 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.

Responsibilities

• Operate polymer synthesis, processing, and analytical testing equipment in support of technical feasibility, development, scaling, and technology transfer initiatives.
• Lead qualification activities (IQ/OQ/PQ) of new equipment, facilities, and processes.
• Define equipment capabilities and process control limits to assure stable and capable performance within specification limits.
• Plan and execute DOE and test protocols that generate rapid insights on processing-structure relationships to further optimize product design.
• Identify and optimize critical formulation and process parameters to deliver robust, capable, and high yielding manufacturing processes.
• Develop and validate testing methodologies for process control and finished good QC release testing to ensure product specifications are consistently met.
• Collaborate with raw material suppliers, equipment vendors, and other external partners to meet project deliverables and accelerate timelines.
• 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.
• Prepare and present technical reports and data-driven recommendations to stakeholders and leadership
• Train and perform all work in accordance with Dexcom’s quality management system.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees