Sr Process Development Engineer
Dexcom, Inc

Job Info

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About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported expected full-year 2021 revenues of $2.48B, a growth of 27% over 2020. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 6,000 people worldwide.

Summary:

In this role as a Senior Engineer - Process Development, you will use sound and proven engineering principles to assist in designing and developing processes and requirements. The projects and activities will focus on Dexcom's sensor technology. Working as a member of a technology team, you will collaborate with other engineers, management, and operators. This position will lead efforts to prove out manufacturing and automation processes to achieve design requirements specified by R&D, and explore and evaluate new technologies and concepts through analysis, prototyping, fixture design, and experimentation.

This position will transfer and scale up new products from R&D. Involvement may begin from feasibility at vendors to full scale manufacturing.

Essential Duties and Responsibilities:

• Design, document and optimize new manufacturing process/assembly steps and operating procedures for new stations, equipment, and processes within a regulated quality system.
  
• Demonstrate hands-on process understanding and provide guidance and training with pilot plant operators on engineering level builds.
  
• Develop and maintain project timelines and provide updates and feedback to project leadership.
  
• Design and develop fixtures and equipment components required to meet process goals from concept to implementation.
  
• Create and release equipment specifications and drawings, establish calibration and preventative maintenance requirements.
  
• Implement, characterize, and optimize processes, mechanical tests, and fixtures/jigs for assembly, inspection and test through implementation of measurement systems, part inspections, MSA, and capability analysis.
  
• Identify process risks and track mitigations through standard methods.
  
• Assist in scaling up equipment and processes from prototype to pilot to full scale manufacturing. Provide design and assembly requirements working within scope as determined by business and schedule needs.
  
• Plan and perform Design of Experiments (DOE) to characterize and determine optimal processing methods
  
• Collaborate with external vendors to produce equipment, materials, and/or parts that meet determined product specifications
  
• Perform statistically robust and industry standard analysis of data, and present findings to technical teams
  
• Exercise judgment within defined procedures and policies to determine appropriate action.
  
• This position assumes and performs other duties as assigned.
  
• Demonstrate hands-on process understanding and provide guidance and training to operators and techs on engineering builds
  
• Assist in the development of project timelines and provide technical updates and feedback to project leadership
  
• Design and develop fixtures and equipment components required to meet process goals from concept to implementation
  
• Assist in scaling up equipment and processes from prototype to pilot to full scale manufacturing
  
• This position assumes and performs other duties as assigned.
  

Required Qualifications:

• Proven track record of running self-directed projects, maintaining aggressive timelines, and executing in a fast-paced environment
  
• Mastery of statistical process control, design of experiments, and critical parameter development/management
  
• Experience executing Measurement System Analysis, and Gage Reliability & Reproducibility studies
  
• Experience developing and executing IQ/OQ/PQ
  
• Strong proficiency with data analysis methods and statistical analysis software (i.e. JMP, Minitab or equivalent)
  
• Experience launching products in regulated industry (e.g. medical device, pharma)
  
• Proficiency in the use of SolidWorks or equivalent CAD software
  
• Knowledge of high reliability, high volume manufacturing processes and designs
  
• Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things
  
• Demonstrated competency in experimental design, execution, and interpretation of data to drive critical product/process decisions
  
• Detail oriented with strong time management skills
  
• Excellent communication (written and verbal) and conflict management skills
  

Preferred Qualifications:

• Medical device experience
  
• Lean Six Sigma or Six Sigma DMAIC methodology
  
• Understanding of CPDM/DFSS concepts
  
• Understanding of industry best practices (e.g. Industry 4.0 concepts)
  
• Manufacturing or sustaining experience
  
• Experience in DFA/DFM
  
• Sterilization, stability, and biocompatibility
  

Exempt Salary Details:

The annual base salary range for this role is $87,000.00 to $145,000.00. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.

Functional Description

Develops new or modified process formulations, defines processing or handling equipment requirements and specifications, and reviews processing techniques and methods applied in the manufacture, fabrication, and evaluation of products. Involvement may begin at any step from pilot plant to full-scale manufacturing. Coordinates design requirement review with appropriate engineering/scientific personnel to ensure compatibility of processing methods. Compiles and evaluates test data to determine appropriate limits and variables for process or material specifications. May conceive and plan projects involving definition and selection of new concepts, equipment automation technology, and approaches in the processing or development of new or improved processes.

Functional/Business Knowledge

• Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.

Scope

• Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Judgement

• Exercises good judgment in selecting methods and techniques for obtaining solutions.
• Normally receives little instruction on day-to-day work, general instructions on new assignments.

Experience and Education

• Typically requires a Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.

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 talentacquisition@dexcom.com.

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 talentacquisition@dexcom.com.

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

UnitedHealthcare 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://transparency-in-coverage.uhc.com/.

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.

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