Senior Process Development Engineer, Scale-Up

Biolinq; San Diego (CA); On-site; USD 130,000 - 155,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Paid time off

Job summary

A digital health company in San Diego is seeking a skilled engineer to develop manufacturing processes and ensure compliance with FDA and ISO standards. The role requires strong leadership, experience in mechanical or bioengineering, and proficiency in process development. Ideal candidates will have a passion for innovation in the health tech sector and the ability to collaborate effectively across teams.

Qualifications

• Minimum 8-12 years related experience, including higher-level education.
• Experience in design of experiments and statistical tools.

Responsibilities

• Develop processes, fixtures, and equipment that meet business needs.
• Support R&D on identifying critical to quality attributes.
• Document engineering tradeoffs for process transfer.

Skills

Mechanical Engineering

Bioengineering

Strong leadership skills

Proficiency in Microsoft Office

Statistical software

Education

BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, or related field

Tools

Solidworks

JMP

Minitab

Job description

A digital health company in San Diego is seeking a skilled engineer to develop manufacturing processes and ensure compliance with FDA and ISO standards. The role requires strong leadership, experience in mechanical or bioengineering, and proficiency in process development. Ideal candidates will have a passion for innovation in the health tech sector and the ability to collaborate effectively across teams.