Sr Process Development Engineer

Dexcom • San Diego, CA

2d • $91,400 - $152,300

About The Position

The Global Engineering team works in new product introduction as the bridge between R&D and operations. The Sensor Process Development team specifically focuses on designing and qualifying new processes from initial pilot and clinical builds to product launch and supporting through scale-up stabilization. This includes manufacturing process automation, test method development, specification development, and product stability testing throughout various stresses seen in commercial production and use. This team works very closely with R&D on the latest and novel technologies and concepts for glucose sensing subsystems. We are looking for someone with a thorough understanding of medical device development and a practical problem solver to join a fast-paced and supportive environment!

Requirements

• Strong background in risk management, root cause analysis, experimental design, and the ability to use statistical analysis to make data-backed conclusions
• Ability to independently manage projects, timelines, and influence project teams to deliver useful and scalable solutions
• Demonstrated ability to qualify and validate equipment and test methods
• Highly organized and detail-oriented with a strong analytical and broad engineering mindset
• Understand how to troubleshoot analytical processes in the medical device or pharmaceutical field, and can quickly design experiments or test plans to scope problems and find solutions
• Proficient in technical writing, verbal and visual communication, and have a demonstrated ability to coordinate and prioritize work to close-out project objectives on time
• Bachelor’s degree, or higher degree, in Bioengineering, Biomedical Engineering, Chemical Engineering, Materials Science and Engineering, Chemistry, or related field with experience in the biotech, pharmaceutical, or medical device industry
• 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.

Nice To Haves

• Training in Lean Six Sigma or other advanced practical statistical applications

Responsibilities

• Lead process development/scale up and characterization, test method development, and integration of new products and processes from R&D, focused on the sensor performance space in test method development, sterilization, and product monitoring
• Drive an understanding of system level trade-offs and interactions of biosensor physiology with underlying scientific challenges of sterilization, storage, distribution, and root cause product failure modes
• Optimize analytical methods for quantifying the effects of stresses in commercial product use on sensor performance including aging, sterilization, global distribution stresses, wear, etc.
• Solve problems where the path forward is ambiguous and cross-functional
• Thrive on a diverse cross-functional team and across sites to implement global engineering solutions
• Partner with development and sustaining operations teams in the globally to align commercial feasibility and collaborate on implementation plans as technologies mature

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior