Sr. Process Development Engineer

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

We are seeking a Senior Process Development Engineer to join a growing medical device engineering team focused on catheter technologies and minimally invasive medical devices. This role is ideal for an engineer who enjoys bridging research and development with commercial manufacturing by developing robust, scalable processes that support product growth from clinical builds to full-scale production.

You will play a key role in process characterization, design-for-manufacturability initiatives, process transfer activities, and new product introduction efforts.

Key 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 contract manufacturers (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.

Required 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.

Preferred Qualifications

• Experience with catheter shaft manufacturing and assembly processes.
• Knowledge of soldering, laser welding, or resistance welding technologies.
• Experience supporting both internal manufacturing operations and external contract manufacturers.
• Background working in smaller or fast-paced medical device companies.
• Comfortable contributing hands-on to documentation, development, and technical design activities.

Ideal Candidate

The ideal candidate combines strong process development expertise with hands-on medical device experience. They are comfortable working across R&D and manufacturing teams, leading process scale-up efforts, and creating robust, repeatable processes that support commercial success.

• Competitive base salary (Senior-level target around $155,000, depending on experience)