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Staff Process Development Engineer
2 months ago
Dexcom is a pioneering company in the field of continuous glucose monitoring (CGM). With a strong commitment to improving human health, we are driven by a passionate team of individuals who strive to make a meaningful impact. Our mission is to empower people to take control of their health, and we are dedicated to developing innovative solutions that address important health challenges.
Job SummaryWe are seeking a highly skilled Staff Process Development Engineer to join our Engineering team. As a key member of our team, you will play a pivotal role in leading, developing, and optimizing manufacturing processes for medical devices. Your expertise in equipment design, test method development, statistical analysis, and process development will be essential in ensuring the robustness, efficiency, and compliance of our processes with regulatory standards.
Key Responsibilities- Lead and manage process development projects from concept through commercialization, adhering to timelines and regulatory constraints.
- Design and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvement.
- Gather and analyze data using statistics, Measurement Systems Analysis, and Design Of Experiments efforts and their associated analysis tools.
- Collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless roll out of processes into production.
- Provide technical expertise in equipment selection, qualification, and validation, ensuring equipment meets performance and regulatory requirements.
- Develop and execute test methods and protocols to validate process performance and product quality.
- Plan, design, develop, and execute production cost and/or quality improvement projects including all necessary documentation.
- Develop and provide status presentations from the technical team up through executive leadership.
- Mentor and guide junior engineers, fostering a culture of continuous learning and development within the team.
- Develop and execute testing and verification, and documentation activities.
- Follow design, quality, and safety guidelines based on GMP, FDA, and ISO guidelines and related Quality and Safety Standards and Practices.
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field; Master's degree preferred.
- Relevant experience within the medical device industry, with demonstrated proficiency in project leadership.
- Proven expertise in equipment design, test method development, statistical analysis, and process development.
- Experience in at least 1 of the following areas; plastic component assembly, needles, adhesives, epoxies and packaging (sterile barrier, secondary, tertiary).
- Experience with statistics, Measurement Systems Analysis, and Design Of Experiments efforts and their associated analysis tools.
- Strong understanding of regulatory requirements (FDA, ISO, etc.) and experience in developing processes compliant with these standards.
- Excellent problem-solving skills and the ability to apply engineering principles to resolve complex technical challenges.
- Effective communicator with the ability to present technical information to diverse audiences and stakeholders.
- Experience with CAD software (e.g., SolidWorks) and statistical analysis software (e.g., JMP, Minitab) is highly desirable.
- Project management certification (PMP) or Six Sigma certification (e.g., Black Belt) is a plus.
- Experience with Databases and queries for data collection, aggregation, and analysis.
- 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.
