Staff Analytical Scientist

Dexcom • San Diego, CA

6d

About The Position

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: Dexcom analytical team is looking for a Staff Scientist with expert level experience in analytical method development, method validation, and specification development for company's next generation materials. Someone who is proactive in driving analytical innovation, works well independently and within cross-functional team. Knowledge and awareness to medical product life cycle and applicable rules and regulations is a plus. Where you come in: You will lead the design, development, and validation of analytical test methods applicable to medical device applications. You will serve as a SME or tech lead in a cross-functional team driving technical solution or decision pertinent to analytical matters. You will work with cross-functional teams to organize in-take as well as providing advice on material supply, biocompatibility, safety, scalability and other operation related design inputs and consultation. You will identify critical material and process attributes, develop, and implement analytical instrument and test methods for in-process and material quality control under Dexcom QMS systems. You will apply design of experiment and statistical analysis to drive the evidence-based conclusion and recommendation, author technical report and protocol, present results for stage-appropriate technical design review and decision making. You understand and apply basic laboratory safety protocols, chemical hygiene, and dispose chemical waste according to company and local EHS regulations. What makes you successful: Must be knowledgeable of analytical techniques and instrumentation for polymers and composites, able to elucidate polymer structure-properties relationship and process impact. Have extensive experiences connecting materials CQAs to field observations and product performance. Act as project/tech lead to collaborating with stakeholders with excellent communication skills and being ready to have hands wet to work in the analytical lab. Have strong technical expertise to build up new capabilities and workflows for the team. Educate and influence stakeholders on the best path by utilizing statistical analysis to make data-based conclusions.

Requirements

• Must be knowledgeable of analytical techniques and instrumentation for polymers and composites, able to elucidate polymer structure-properties relationship and process impact.
• Have extensive experiences connecting materials CQAs to field observations and product performance.
• Act as project/tech lead to collaborating with stakeholders with excellent communication skills and being ready to have hands wet to work in the analytical lab.
• Have strong technical expertise to build up new capabilities and workflows for the team.
• Educate and influence stakeholders on the best path by utilizing statistical analysis to make data-based conclusions.
• Extensive hands-on polymer experience with SEC-MALS, NMR, MALDI-TOF and thermal characterizations instruments (TGA, DSC, Rheometer) with capabilities of troubleshooting and repair.
• Experienced in method development and method validation in a pharma or medical device setting, familiar with relevant standards and guidance such as ICH, USP.
• Ability to mentor, develop current and future staff, and work in a fast-paced environment.
• 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.

Nice To Haves

• PhD degree with both aqueous and organic based polymer characterizations experiences is preferred.
• Knowledge and awareness to medical product life cycle and applicable rules and regulations is a plus.

Responsibilities

• Lead the design, development, and validation of analytical test methods applicable to medical device applications.
• Serve as a SME or tech lead in a cross-functional team driving technical solution or decision pertinent to analytical matters.
• Work with cross-functional teams to organize in-take as well as providing advice on material supply, biocompatibility, safety, scalability and other operation related design inputs and consultation.
• Identify critical material and process attributes, develop, and implement analytical instrument and test methods for in-process and material quality control under Dexcom QMS systems.
• Apply design of experiment and statistical analysis to drive the evidence-based conclusion and recommendation, author technical report and protocol, present results for stage-appropriate technical design review and decision making.
• Understand and apply basic laboratory safety protocols, chemical hygiene, and dispose chemical waste according to company and local EHS regulations.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees