Staff Process Development Engineer

Dexcom; San Diego (CA); In loco; USD 111.000 - 185.000; Tempo pieno

Descrizione del lavoro

Dexcom, Inc. in San Diego, CA is seeking a hands-on engineer to lead and support product process development for medical devices.

You will design experiments, perform measurement system analyses, and apply statistics to drive data-driven process targets. You will collaborate across R&D, QA, Regulatory, and Manufacturing to ensure design transfer, process controls, and scalable production while maintaining quality.

Competenze

• Bachelor’s degree in a technical discipline.
• 8–12 years related experience; or 5–7 years with Master’s; or 2–4 years with PhD.

Mansioni

• Lead and support new product process development, design of experiments and measurement system analyses.
• Execute design control activities with emphasis on design transfer and linkage between technical and business requirements, design and process failure modes and controls.
• Review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements.
• Utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls.
• Help develop and execute test methods with necessary protocols and reports to validate process performance and product quality.
• Collaborate cross-functionally with R&D, QA, Regulatory, Supply Chain, and Manufacturing to ensure seamless business strategy and transfer of deliverables in the QMS.

Conoscenze

Experiment design

Measurement system analysis

Statistical methods

Medical device design transfer

Cross-functional collaboration

Presentations (PowerPoint)

Formazione

Bachelor’s degree in a technical discipline

Master’s degree preferred

PhD with related experience

Strumenti

PowerPoint

Descrizione del lavoro

Meet the team:

Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.

Where you come in:

• You will lead and support new product process development, design of experiments and measurement system analyses to collect and analyze applicable data relative to program process development targets.
• You execute design control activities with emphasis on design transfer and an understanding of system design and the linkage between technical and business requirements, design and process failure modes and process controls.
• You will review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements.
• You will utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls.
• You will help develop and execute test methods with necessary protocols and reports to validate process performance and product quality.
• You will collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing to ensure seamless business strategy and transfer of technical deliverables in the quality management system.

What makes you successful:

• You have a degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field; Master’s degree preferred.
• Your proficiency is an understanding of experimental study design and measurement system analysis, including the appropriate statistical approaches to data analysis.
• You bring an understanding of medical device design transfer with knowledge of quality and regulatory standards.
• You have experience in at least 1 of the following areas; Plastic component assembly, needles, adhesives, epoxies and curing, and packaging (sterile barrier, secondary, tertiary boxing)
• You are able to communicate effectively and generate PowerPoint presentations to deliver objectives and outcomes from the technical team up through executive leadership.
• You bring cross-functional collaboration experience amongst peers and leaders.

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 8 12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of 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

AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary:

$111,100.00 - $185,100.00