Medical Device Engineer 2

Dexcom • San Diego, CA

1d

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 R&D Material Science Center, 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 to design, develop, and integrate innovative materials for medical devices. 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 perform qualification activities (IQ/OQ/PQ) of new equipment, facilities, and processes. You will determine 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 testing methodologies for process control and support with QC method transfer 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 train and perform all work in accordance with Dexcom’s quality management system.

Requirements

• You must have hands-on knowledge and experience with wet lab chemistry and processing unit operations, ideally within medical device applications.
• You have high level of hands-on mechanical aptitude and can effectively troubleshoot and repair equipment.
• You have expertise in life science, chemistry, polymer science or polymer engineering.
• You have knowledge in equipment, method, and process qualification and validation activities.
• You are organized, detail oriented, and skilled in problem-solving, with knowledge in DOE methodology, statistics, data analysis tools (JMP, Minitab, 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 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.
• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 2-5 years related experience or Master’s degree and 0-2 years’ equivalent experience.

Responsibilities

• Operate polymer synthesis, processing, and analytical testing equipment in support of technical feasibility, development, scaling, and technology transfer initiatives.
• Perform qualification activities (IQ/OQ/PQ) of new equipment, facilities, and processes.
• Determine 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 testing methodologies for process control and support with QC method transfer
• 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.
• 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