About Dexcom:

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

Summary:
Highly skilled Analytical Scientist with expertise in analytical method develop, method validation, specification development, instrumentation maintenance/repair/ troubleshooting and timely problem solving. In particular: Extractables and Leachables (E&L) experience, Agilent HPLC-QTOF and Quant Analysis and polymer experience are sought after.

The individual is expected to be detail oriented with hands-on aptitude and will provide leading support to material characterization and regular QC release testing. The ideal candidate will have fundamental understanding and training in materials science and related physical/chemical characterization techniques. Someone who is proactive in driving innovation, works well independently and understands the importance and strength of the team. Knowledge and awareness to medical product life cycle and applicable rules and regulations is a plus.

Essential Duties & Responsibilities:

• Design and develop analytical test methods and capability to support the R&D and other business needs with a focus on Extractable and Leachables analysis and Mass Spectrometry


• Lead the experiment design, execution, interpretation, and drive for scientific conclusion and decision to meet the targeted project goals and business objectives


• Work with cross-functional teams to provide analytical support on raw material supply qualification, biocompatibility safety evaluation, and critical-to-quality material properties analysis to establish robust and reproducible product or process performance


• Lead and perform physical and chemical characterization of raw materials, in-process samples and finished goods


• Lead and execute instrument IOQ, test method transfer/development and test method validation activities


• Conduct manufacturing troubleshooting, OOS investigation and CAPA activities


• Compose analytical method protocols, generate technical reports and SOPs for routine testing


• Operate, troubleshoot and maintain analytical instruments (HPLC, GC/MS, GPC, DSC, TGA, Titrator, Rheometer, Instron, SEM, etc.)


• Supervise and train lab techs on new test method, equipment operation, and GLP quality procedures and protocols


• Estimates work schedule, communicates progress and issues to management


• Maintain accurate and up-to-date lab records, notebooks, and other documentation


• Work independently or as a member of the team to complete all required tasks according to schedule


• Understand and apply basic laboratory safety protocols, chemical hygiene, and dispose chemical waste according to Dexcom and local EH&S regulations


• Follow GLP guidelines and comply to all quality and safety requirements.


• Other duties as assigned

Required Qualifications:

• 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.


• Must be knowledgeable of analytical techniques, polymer structure-properties relationship, synthesis and analytical instrumentation


• Must be familiar with instrument troubleshooting and repair

Preferred Qualifications:

• 5+ years of related experience in R&D or manufacturing with an emphasis on the biotech or medical device industry


• Degree in Analytical Chemistry is preferred with a Material Science or Polymer Chemistry degree a plus


• Masters or PhD

Functional Description: Technical Individual Contributors

Provides technical expertise to the design and development of new invasive and noninvasive medical device product(s). Investigates/evaluates existing technology and advises research and development, regulatory affairs, and reliability engineering to ensure appropriate process development under the best possible conditions. Designs and implements new methodologies, materials, machines, processes, or products. Develops new concepts from initial design to market release. Conducts feasibility studies of the design to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.

Functional/Business Knowledge:

• Possesses advanced knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies.

Scope:

• Demonstrates significant technical expertise, collaboration with others and independent thought. Anticipates potential complex problems requiring an in‐depth evaluation. Demonstrates strategic thinking and commercial/industry understanding in functional projects.

Judgement:

• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.


• Determines methods and procedures on new assignments and may coordinate activities of other colleagues.

#LI-FH1

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 Talent Acquisition at talentacquisition@dexcom.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.