Manufacturing Engineer

Meet the team:
Join our Manufacturing Engineering team at the San Diego Innovation Center of Excellence to support the development of products and processes, and transfer into operations, with a primary focus on advancing our applicator technology.

• Lead cross-functional development, validation, and implementation of manufacturing processes to support new product introductions, design changes, and commercial production readiness.
• Drive process capability, quality, and yield improvements through the application of statistical tools such as DOE, SPC, Gauge R&R, and structured root cause analysis.
• Own process validation activities including development and execution of IQ/OQ/PQ protocols, validation strategies, and supporting documentation required for regulatory compliance.
• Provide technical leadership and project management for complex engineering initiatives, coordinating stakeholders across R&D, Manufacturing, Quality, Supply Chain, and Operations.
• Assess and mitigate process and product risks by contributing to PFMEAs, process specifications, validation plans, CAPAs, and change control activities within a regulated quality system.
• Mentor engineers and influence engineering strategy by establishing best practices, providing technical guidance, and leading long‑term process and technology improvement roadmaps.

• Expertise in pilot‑scale or high‑volume manufacturing, process validation, equipment qualification, and measurement systems.
• Project Management leadership in areas focusing on design changes, process improvements, and other plant efficiency efforts, in regulated industries, preferably in the medical device sector.
• Expertise in applying statistical tools used to assist in the development and troubleshooting of products and processes.
• Proven ability to work hands‑on in a fast‑paced environment, multitask, prioritize projects, maintain timelines, and communicate updates to management.
• Demonstrated ability to work cross‑functionally as a team player, with strong critical thinking, mentoring, and coaching skills.

• A front‑row seat to life‑changing CGM technology.
• 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.

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• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8‑12 years related experience, or a Master’s degree and 5‑7 years equivalent industry experience, or a PhD and 2‑4 years experience.

The information contained herein is not intended to be an all‑inclusive list of the duties and responsibilities of the job, nor are they intended to be an all‑inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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.

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