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.
ResponsibilitiesCreate 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.Essential SkillsHands-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.Additional Skills & QualificationsExperience leading engineers or technicians.Familiarity with contract manufacturing or OEM environments.Cultural fit for a team-oriented and collaborative work culture.Work EnvironmentThe 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.
Job Type & LocationThis is a Permanent position based out of San Jose, CA.
Pay and BenefitsThe pay range for this position is $170000.00 - $190000.00/yr.
Medical Insurance, Dental Insurance, Vision Insurance, 401k Program, PTO, Sick Time off.
Workplace TypeThis is a fully onsite position in San Jose,CA.
Application DeadlineThis position is anticipated to close on Feb 5, 2026.
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