Senior Process Development Engineer - Manufacturing Scale-Up

MedTech Innovator; San Diego (CA); On-site; USD 130,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k) plan

PTO

Job summary

A cutting-edge health technology firm in California is seeking an experienced professional responsible for the design, development, and transfer of biosensor technologies. The ideal candidate will have substantial experience in scaling manufacturing processes and a robust understanding of FDA regulations. This position involves developing processes, conducting experiments, and supporting pre-commercial builds. Competitive salary ranging from $130,000 to $145,000 is offered, alongside a comprehensive benefits package.

Qualifications

• Minimum 8-12 years of related experience, including higher-level education.
• Strong understanding of process interactions.
• Expertise in FDA 21 CFR Part 820 and ISO 13485 standards.

Responsibilities

• Support R&D in identifying critical quality attributes and specifications.
• Develop processes and equipment that meet business needs.
• Manage equipment lifecycle through requirements and inductions.
• Design experiments to optimize process variables.

Skills

Scaling manufacturing processes

Design of experiments

Statistical analysis

Leadership

FDA regulations knowledge

Lean manufacturing

Proficiency in Microsoft Office

Experience with CAD software

Education

BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, or Manufacturing Engineering

Tools

JMP

Minitab

Solidworks

ERP Systems

Job description

A cutting-edge health technology firm in California is seeking an experienced professional responsible for the design, development, and transfer of biosensor technologies. The ideal candidate will have substantial experience in scaling manufacturing processes and a robust understanding of FDA regulations. This position involves developing processes, conducting experiments, and supporting pre-commercial builds. Competitive salary ranging from $130,000 to $145,000 is offered, alongside a comprehensive benefits package.