Manufacturing Process Development Engineer

This position is responsible for aspects of the process design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. The role requires compliance with FDA QSR (21 CFR 820) and adherence to the Quality Management System (QMS). The engineer will lead a group of manufacturing engineers, supporting the team with escalations and questions, and managing their KPIs and performance.

• Create and improve manufacturing processes for catheter-based projects.
• Utilize basic concepts of catheter production using equipment such as hot boxes, laminators, coilers, bonding machines, and heat shrink machines.
• Lead and support a team of manufacturing engineers.
• Manage multiple projects in a contract manufacturing environment.
• Handle technical escalations and manage team KPIs.

• Hands-on experience in catheter development and manufacturing.
• Expertise in process development and validation.
• Ability to conduct root cause analysis and design for manufacturing.
• Experience in managing multiple projects simultaneously.

• Experience leading engineers or technicians.
• Familiarity with contract manufacturing or OEM environments.
• Cultural fit for a team-oriented and collaborative work culture.

The work environment is family-friendly with a focus on collaboration across departments, as demonstrated by a 98% retention rate. It offers flexibility to prioritize personal and family life needs and operates without micromanaging, fostering a supportive and drama-free workplace.

This is a Permanent position based out of San Jose, CA.

The pay range for this position is $170000.00 - $190000.00/yr.

Medical Insurance, Dental Insurance, Vision Insurance, 401k Program, PTO, Sick Time off.

This is a fully onsite position in San Jose,CA.

This position is anticipated to close on Feb 5, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $170,000 - $190,000