Senior Process Development Engineer

BioTalent; Hayward (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BioTalent in Hayward, CA seeks a Sr. Process Development Engineer, Catheter Engineering to advance next-generation catheter devices from early development to commercial manufacture.

You will develop robust, scalable production processes and support design transfer in a regulated medical device environment. You will lead manufacturing process development across extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser processing, while performing DFM/DFA, FMEA, and SPC

Qualifications

• Bachelor's degree in a relevant field.
• Minimum 5 years of medical device process development or manufacturing engineering experience.
• At least 3 years working with catheter-based devices.
• Hands-on experience with catheter manufacturing processes (extrusion, braiding, thermal bonding, adhesive assembly, tip forming, laser processing).
• Proficiency with CAD software, preferably SolidWorks.

Responsibilities

• Lead process development activities to transition catheter devices from prototype to commercial manufacturing.
• Develop and optimize catheter manufacturing processes (extrusion, braiding, thermal bonding, adhesive assembly, tip forming, laser processing).
• Perform DFM/DFA assessments, tolerance stack-up analyses, and establish component specifications and inspection criteria.
• Support process validation activities (IQ/OQ/PQ), FMEAs, risk assessments, and manufacturing readiness.
• Develop electrical assembly processes for catheter-integrated components (wire terminations, cable assemblies, SMT).
• Collaborate with Manufacturing, Quality, Regulatory, R&D, suppliers, and contract manufacturers to improve processes and ensure compliance.
• Establish SPC methods, Cp/Cpk, inspection methods, and process monitoring systems.
• Create manufacturing work instructions, assembly procedures, and support ECOs.
• Apply lean manufacturing principles and lead continuous improvement initiatives to reduce waste.

Skills

Medical device process development

Lean manufacturing

DFM/DFA analyses

Catheter manufacturing knowledge

Education

Bachelor's degree in Mechanical Engineering/Biomedical Engineering/Manufacturing Engineering or related field

Tools

SolidWorks

Job description

Location: Hayward, CA

About the Role

We are partnering with an innovative medical device company to find a Sr. Process Development Engineer, Catheter Engineering. In this role, you'll help transition next-generation catheter-based devices from early-stage development into commercial manufacturing by developing robust, scalable production processes, supporting design transfer activities, and driving process improvements in a regulated medical device environment.

Key Responsibilities

• Lead process development activities to transition catheter devices from prototype and first-in-human stages into commercial manufacturing.
• Develop and optimize catheter manufacturing processes, including extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser cutting.
• Perform DFM/DFA assessments, tolerance stack-up analyses, and establish component specifications and inspection criteria.
• Support process validation activities (IQ/OQ/PQ), process FMEAs, risk assessments, and manufacturing readiness efforts.
• Develop electrical assembly processes for catheter-integrated components, including wire terminations, cable assemblies, and surface mount components.
• Collaborate with Manufacturing, Quality, Regulatory, R&D, suppliers, and contract manufacturers to improve processes and ensure compliance.
• Establish SPC methods, capability studies (Cp/Cpk), inspection methods, and process monitoring systems to support production stability.
• Create manufacturing work instructions, assembly procedures, and support engineering change orders (ECOs).
• Apply lean manufacturing principles and lead continuous improvement initiatives to improve efficiency and reduce waste.

Qualifications & Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Materials Science, or a related field.
• Minimum 5 years of medical device process development or manufacturing engineering experience, including at least 3 years working with catheter-based devices.
• Hands-on experience with catheter manufacturing processes such as extrusion, braiding, thermal bonding, adhesive assembly, tip forming, and laser processing.
• Proficiency with CAD software, preferably SolidWorks.

This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future.