Sr Staff QA Engineer

Description

The company is a pioneer and global leader in continuous glucose monitoring (CGM), founded about 25 years ago and now expanding beyond diabetes into consumer health technology.

The Design Quality Engineering (DQE) team drives Design for Excellence (DfX) across the lifecycle of marketed products and future innovations, and leads strategy and outcomes for Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality processes.

This role is the DQE subject matter expert for material characterization, formulation science, and material-related risk across advanced technology, new product development, and lifecycle programs.

Responsibilities

• Lead quality oversight of characterization and qualification strategies for raw materials, intermediates, formulations, and finished materials, especially polymers, enzymes, reagents, adhesives, coatings, membranes, and other critical materials.
• Build clear traceability between material attributes, formulation characteristics, manufacturing processes, design inputs, and the safety, performance, and user needs of the finished device.
• Work with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs so that material and formulation decisions rest on solid scientific evidence and sound quality engineering.
• Make risk-based decisions using ISO 14971, identifying, evaluating, controlling, and verifying material-related hazards, failure modes, and variability.
• Provide Design Quality leadership for characterization studies, analytical method assessments, stability programs, material compatibility evaluations, and verification work that shows product safety and essential performance.
• Represent Design Quality in design reviews, audits, inspections, and regulatory submissions, explaining how material characterization, risk controls, and device performance connect.

Requirements

• Deep technical expertise in material characterization, analytical chemistry, formulation development, or material science, gained in medical device, IVD, biotechnology, combination product, or pharmaceutical work.
• Demonstrated experience characterizing and qualifying complex materials such as polymers, enzymes, biological reagents, sensor chemistries, adhesives, coatings, or other critical materials used in regulated products.
• A strong grasp of how raw material, intermediate, and formulation characteristics affect the safety, effectiveness, reliability, and essential performance of a finished device.
• Proven use of ISO 14971 to set up and maintain traceability between material attributes, critical quality attributes, and product-level risks.
• Experience with Design Controls, verification and validation, design transfer, and regulatory submissions in a regulated environment.
• Skill in reviewing and interpreting analytical, chemical, physical, biological, and statistical data to make sound, risk-based quality decisions.
• Strong collaboration, communication, and influencing skills, with the ability to work effectively in highly technical, multidisciplinary teams.
• At least 8 years of experience in medical device, pharmaceutical, biotechnology, or combination product development and quality engineering.
• A Bachelor's degree in Chemistry, Chemical Engineering, Materials Science, Polymer Science, Biochemistry, Biomedical Engineering, Pharmaceutical Sciences, or a related technical field is required; an advanced degree (MS or PhD) is preferred.
• Typically a Bachelor's degree in a technical discipline plus 13+ years of related experience, or a Master's degree plus 8+ years of equivalent industry experience, or a PhD plus 5+ years of experience.

Conditions

Travel is 0-5%.

Flex workplace: your primary location is a home office with no assigned workstation, and office visits are agreed with your manager. You must live within commuting distance of your assigned site, typically 75 miles (120 km).

Salary range: $128,600.00 - $214,400.00.

Posted under the US location code.

AI-supported tools may assist with hiring steps, but people make all hiring decisions.

The company is an equal opportunity employer.

Benefits

• Work close to CGM technology that changes lives, and join an employee community built around it.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through in-house learning programs and/or qualified tuition reimbursement.