Meet the team:Our Manufacturing Process Engineering team is part of the San Diego Innovation Center of Excellence, driving the development, transfer, and scale-up of manufacturing processes and equipment for new products. In the Pilot Manufacturing environment, we focus on bridging R&D product concepts and full-scale production-developing robust processes, characterizing performance, and ensuring compliance with Design Control requirements.
The Process Engineering Manager plays a critical role in leading technical strategy and execution for process development and characterization, enabling successful commercialization of innovative products within a regulated environment.
Where you come in:As Process Engineering Manager, you will provide technical leadership to a team of engineers and scientists to:
- Lead process development, process characterization, and support pilot manufacturing, ensuring processes are robust, well-defined, and compliant with Design Controls, ISO 13485, FDA compliance, and regulatory requirements.
- Define and oversee Design of Experiments (DOE) to characterize processes, validate changes, and optimize performance using statistical analysis tools (Gauge R&R, Cp/Cpk, SPC).
- Manage the documentation and execution of experimental requests on pilot manufacturing lines, ensuring proper process controls, traceability, and alignment with product design requirements and Design Development Plans.
- Monitor pilot line performance, identify trends, and drive improvements through data-driven decision-making and continuous improvement strategies.
- Interpret build data and process metrics to assess variability, identify root causes, and implement corrective actions using advanced statistical methods.
- Oversee the transfer and sustaining of processes, test methods, and equipment from development into pilot operations, ensuring product functionality and cost-effectiveness.
- Collaborate cross-functionally with R&D, Quality, and Operations to align on process specifications, risk management (PFMEA), and validation strategies (IQ, OQ, PQ).
- Provide hands-on technical guidance for manufacturing workflows, specialized equipment, analytical testing tools, and pilot-scale facilities within a regulated environment.
- Champion New Product Introduction (NPI) roadmaps and strategies, driving innovation and operational excellence.
- Select, develop, and mentor engineering talent, fostering a culture of technical rigor and collaboration.
- Ensure compliance with safety, environmental, and quality standards across all pilot manufacturing activities, supporting regulatory submissions as needed.
What makes you successful:The Process Engineering Manager is responsible to maintain proper product functionality, develop and sustain manufacturing processes, and equipment within the San Diego Manufacturing site through:
- Proven experience managing engineers and scientists, with cross functional disciplines, focused on manufacturing processes, product release testing, and investigations.
- Knowledge of DMAIC process, structure problem solving, lean manufacturing and project management with proven success of implementation.
- Proven engineering experience supporting and managing regulated GMP/GLP operations, preferably in medical device, medical diagnostic, and/or pharmaceutical industries.
- Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems).
- Excellent written and oral skills, driving efficient and effective communication cross functionally.
- Proven ability to collaborate and drive results in a matrix organization.
- Recommended to have a STEM degree with proven ability to work hands-on in a fast-pasted environment with competing priorities.
What you'll get: - 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.
Travel Required: Education and Experience:- Typically requires a Bachelor's degree in a technical discipline with 8-12 years of industry experience
- 2-5 years of previous management or lead experience
Please note: 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.
Salary:
$122,500.00 - $204,100.00
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