Staff Process Development Engineer

Posted Yesterday
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San Diego, CA
111K-185K Annually
Senior level
Healthtech • Biotech
The Role
Lead process development and scale-up for new medical devices, focusing on sterilization and sensor performance. Collaborate with cross-functional teams, optimize analytical methods, and mentor junior engineers. Manage projects by coordinating timelines and addressing technical challenges.
Summary Generated by Built In

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:

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 sterilization and sensor performance space
  • You will drive an understanding of system level trade-offs and interactions of the sensor physiology with underlying scientific challenges of sterilization, transit, and root cause understanding of product failure modes
  • You will design processes and partner with bench, pre-clinical, clinical, qualification teams, and field data as needed to build out correlations of in vitro and in vivo performance
  • You will optimize analytical methods for quantifying the effects of stresses in commercial product use on sensor performance including aging, sterilization, storage/shipping excursions, wear, etc.
  • You will solve problems where the path forward is ambiguous and cross-functional
  • You will mentor and foster the growth of junior engineers as a technical lead on the team
  • You will partner with development and sustaining operations teams to align on commercial feasibility and collaborate on implementation plans as technologies mature

What makes you successful:

  • Your knowledge of sterilization techniques, especially ethylene oxide batch processing, and analytics and ability to provide direct, candid feedback will produce critical insight to improve our products and processes
  • You can independently manage projects, timelines, and influence project teams to deliver useful and scalable solutions
  • You are highly organized and detail-oriented with a strong analytical and broad engineering mindset.
  • You understand how to troubleshoot batch processes in the medical device or pharmaceutical field, and can quickly design experiments or test plans to scope problems and find solutions
  • Your proficiency in technical writing, verbal and visual communication, and demonstrated ability to coordinate and prioritize work helps close-out project objectives on time
  • You have a Bachelor’s degree, or preferably higher degree, in Bioengineering, Biomedical Engineering, Chemical Engineering, Materials Science and Engineering, Chemistry, or related field with significant experience in 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 and a minimum of 8-12 years of related experience. • At this level a graduate degree may be desirable with 4 years of related experience

Flex Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).

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 [email protected]

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 [email protected]

View the OFCCP's Pay Transparency Non Discrimination Provision at this link. 

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

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
 

Salary:

$111,100.00 - $185,100.00

The Company
Chatswood, New South Wales
7,214 Employees
On-site Workplace
Year Founded: 1999

What We Do

Dexcom Corporation 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 over 10,000 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

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