Sr Process Development Engineer

Dexcom Inc.; San Diego (CA); Sur place; USD 91 000 - 152 000; Plein temps

Avantages offerts par ce poste

Growth opportunities on a global scale

Career development programs

Industry-leading organization

Résumé du poste

Dexcom in San Diego, CA, seeks a senior engineer to lead process development and scale-up for sensor performance. You will develop test methods, address sterilization and product monitoring, and drive integration of new processes from R&D to launch.

You will apply risk management, experimental design, and statistical analysis in a medical device context, working with cross-functional teams to deliver scalable solutions.

Qualifications

• Bachelor’s degree in a technical discipline with 5–8 years related experience, or Master’s with 2–5 years, or PhD with 0–2 years.
• Experience in medical device development and practical problem solving.
• Ability to qualify and validate equipment and test methods, Lean Six Sigma training preferred.

Responsabilités

• Lead process development, scale-up and characterization, test method development.
• Integrate new products and processes from R&D, focusing on sensor performance, sterilization, and monitoring.
• Understand system-level trade-offs of biosensor physiology with sterilization, storage, and distribution.
• Optimize analytical methods to quantify effects of stresses on sensor performance from aging to wear.
• Solve problems where path forward is ambiguous and work cross-functionally.
• Collaborate with development and sustaining operations across sites to align feasibility and implementation plans.

Connaissances

Risk management

Root cause analysis

Experimental design

Statistical analysis

Project management

Lean Six Sigma

Technical writing

Communication

Attention to detail

Analytical mindset

Formation

Bachelor’s or higher in Bioengineering, Biomedical Eng, Chemical Eng, Materials Science & Eng, Chemistry

Description du poste

Meet the team:

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!

Where you come in:

• You will 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
• You will 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
• You will optimize analytical methods for quantifying the effects of stresses in commercial product use on sensor performance including aging, sterilization, global distribution stresses, wear, etc.
• You will solve problems where the path forward is ambiguous and cross-functional
• You will thrive on a diverse cross-functional team and across sites to implement global engineering solutions
• You will partner with development and sustaining operations teams in the globally to align commercial feasibility and collaborate on implementation plans as technologies mature

What makes you successful:

• You have a strong background in risk management, root cause analysis, experimental design, and the ability to use statistical analysis to make data-backed conclusions
• You can independently manage projects, timelines, and influence project teams to deliver useful and scalable solutions
• You have a demonstrated ability to qualify and validate equipment and test methods, and preferably training in Lean Six Sigma or other advanced practical statistical applications
• You are highly organized and detail-oriented with a strong analytical and broad engineering mindset
• You 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
• You are 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
• You have a 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

What you’ll get:

• 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.

Travel Required:

• 5-15%

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.

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. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

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 [e-mail].

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: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

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Salary:

$91,400.00 - $152,300.00