Senior Process Engineer — Medical Device Process Dev

RXinsider LTD.; San Diego (CA); On-site; USD 91,000 - 152,000; Full time

Benefits offered by this job

Benefits program

Global growth

Career development

Tuition reimbursement

Job summary

Dexcom in San Diego, CA is hiring a Senior Process Development Engineer to join the Global Engineering Organization. You will support process development, validation and implementation for mechanical and analytical test methods, collaborating with Manufacturing, Quality, R&D and Supplier Quality to enable material characterization and production support.

The role requires a technical bachelor’s degree with 5–8 years of related experience (or a higher degree) and hands-on lab, manufacturing and

Qualifications

• Bachelor's degree in a technical discipline (bio/chem/biomed/ME/CE) or related field.
• Experience with process development and manufacturing processes.
• Ability to perform hands-on lab, manufacturing and test activities.
• Familiarity with DOE, statistics, data visualization, and software tools.
• Experience in regulated medical devices (FDA 21 CFR 820, ISO 13485).

Responsibilities

• Support process and test method development for manufacture and testing of materials and products.
• Define process/test requirements from inputs, materials, performance parameters.
• Plan, execute and document experiments to characterize new processes and test methods.
• Compile, trend and evaluate test data to define process limits.
• Collaborate with Manufacturing, Quality, Automation, Software, Analytical Chemistry and other teams.
• Prepare technical documentation including protocols, reports, procedures, risk inputs (pfMEA).
• Participate in design reviews, process reviews, failure investigations and continuous improvement.

Skills

Process development

Lab execution

Data analysis

Documentation

Education

Bachelor's degree in technical discipline

Advanced degree (MS/PhD)

Tools

JMP

Minitab

Python

Excel

Job description

Dexcom in San Diego, CA is hiring a Senior Process Development Engineer to join the Global Engineering Organization. You will support process development, validation and implementation for mechanical and analytical test methods, collaborating with Manufacturing, Quality, R&D and Supplier Quality to enable material characterization and production support.

The role requires a technical bachelor’s degree with 5–8 years of related experience (or a higher degree) and hands-on lab, manufacturing and