Staff Formulation Membrane Engineer

Dexcom • San Diego, CA

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About The Position

As a key member of the material science group within Dexcom’s research and development organization, the Staff Membrane Formulation Engineer is responsible for developing and validating novel membrane material formulation designs to address critical needs in cutting edge biosensor health products. The individual is expected to have a clear understanding of the technical and business challenges associated with biomaterial development in a regulated environment. Emphasizing expertise in thin film polymer membranes, polymer solution and colloidal science, and formulation engineering, the scientist will work cross functionally to drive the creation of design requirements, down select formulation chemistry, develop and validate design/process to final specification, identify and mitigate risks, interface with external partners and collaborate with internal stake holders to drive projects to completion.

Requirements

• Demonstrated knowledge of, and experience with, polymer material science and engineering for product safety and form, fit, and function - preferably in Class III medical applications.
• Expertise in material formulation engineering, thin film polymer membrane technology, polymer solution and colloidal science, rheology, and thin film coating deposition process technologies.
• Experience with polymer emulsions, dispersions and other water-based coating chemistries.
• Experience with thin-film bulk and surface characterization (e.g. morphology, thickness, chemistry).
• Experience with medical device driven product development, V-diagram design input - output relationships, risk management, and related documentation practices.
• Knowledge of Quality Systems Regulations 21CFR Part 820 and standards (ISO 13485, ISO 9001).
• Highly organized and detailed oriented.
• Excellent communication (written and verbal), collaboration, and interpersonal skills.
• Excellent work ethic, ability to deal with ambiguity/uncertainty, and willingness to learn.
• Proven ability to work hands-on 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

• Experience with project management is highly desirable.
• Experience with experimental design and planning, assay development, statistics, DOE methodologies, data analysis methods and software (JMP preferred).

Responsibilities

• Drive material science excellence as a technical leader in thin film polymer membrane technology and polymer solution and colloidal science for various biosensor membrane modalities.
• Develop polymer binder-based membrane formulation designs that meet desired system level performance, safety, process, scale, and cost requirements.
• Plan and execute hands-on laboratory experiments, identify critical variables and design trade-offs, down-select and optimize critical formulation variables for form-fit-function on targeted applications while tracking and managing risk.
• Initiate and develop characterization tools and test methods to generate insights into structure-property-performance relationships and hence accelerate development cycle time.
• Plan and execute validation protocols and reports related to formulation preparation process, formulation deposition process pot-life and shelf-life.
• Prepare technical documentation, data analyses, and presentations in compliance with GxP standards to guide product development and ensure alignment with FDA and international regulatory requirements.
• Identify, procure, and qualify critical raw materials and manage suppliers to support formulation development and commercialization.
• Perform comprehensive literature and patent reviews to identify new opportunities and materials for next-generation biosensor health products.
• Contribute to new IP generation efforts and with evaluation of technical, clinical, and commercial risks.
• Understand and adhere to all relevant laboratory safety protocols, chemical hygiene, and dispose of chemical waste according to company and local EH&S regulations.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees