Senior Process Engineer - Catheter Manufacturing & Scale-Up

BioTalent; Hayward (CA); On-site; USD 140,000 - 171,000; Full time

Job summary

BioTalent is seeking a Senior Process Development Engineer to join a growing medical device engineering team focused on catheter technologies and minimally invasive devices. This role bridges R&D with commercial manufacturing by developing robust, scalable processes from clinical builds to full-scale production.

You will lead process characterization, design-for-manufacturability initiatives, process transfer activities, and new product introduction efforts across cross-functional teams.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 5+ years of engineering experience, including at least 3 years focused on process development.
• Hands-on experience developing manufacturing processes for catheter-based devices or other flexible medical instruments.
• Strong experience with: Design of Experiments (DOE), Process validation, Tolerance stack analysis.
• Demonstrated experience moving products from development into manufacturing environments.
• Excellent problem-solving, analytical, and technical documentation skills.

Responsibilities

• Lead process development activities for catheter-based medical devices and related components.
• Develop and execute process characterization studies using Design of Experiments (DOE).
• Drive Design for Manufacturability (DFM) improvements to enhance product quality, reliability, and scalability.
• Support scale-up activities from clinical manufacturing to commercial production.
• Lead process validation efforts and ensure manufacturing readiness.
• Manage process transfer activities between development and production environments, including collaboration with CMOs.
• Support New Product Introduction (NPI) initiatives and manufacturing process implementation.
• Conduct tolerance stack analyses and Gauge R&R studies to improve process capability.
• Generate and maintain technical documentation, protocols, reports, and engineering records.
• Partner closely with R&D, Quality, Manufacturing, and Operations teams to ensure successful product launches.

Skills

Process development

DOE

Process validation

Tolerance stack analysis

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Soldering

Laser welding

Resistance welding

Job description

BioTalent is seeking a Senior Process Development Engineer to join a growing medical device engineering team focused on catheter technologies and minimally invasive devices. This role bridges R&D with commercial manufacturing by developing robust, scalable processes from clinical builds to full-scale production.

You will lead process characterization, design-for-manufacturability initiatives, process transfer activities, and new product introduction efforts across cross-functional teams.