Zeus · 20 hours ago
Manufacturing Engineering Manager
San Jose, CA
Full-time
Onsite
Senior Level
$165K/yr - $180K/yr
5+ years expZeus is a company focused on manufacturing engineering, and they are seeking a Manufacturing Engineering Manager to provide support for catheter production and lead process development initiatives. The role involves managing a team, optimizing manufacturing processes, ensuring compliance with regulations, and driving continuous improvement efforts.
ManufacturingPlastics and Rubber Manufacturing
Responsibilities
Provide day-to-day manufacturing engineering support for catheter production, including troubleshooting yield, quality, and throughput issues
Serve as the escalation point for complex technical issues affecting safety, quality, delivery, or cost
Partner with Production, Quality, and R&D to ensure manufacturing processes consistently meet product specifications and customer requirements
Support introduction of new products into manufacturing, including line setup, pilot builds, and transition to sustained production
Lead development, optimization, and sustainment of manufacturing processes for catheter components and assemblies, including extrusion, braiding, lamination, bonding, coating, tip forming, and final assembly
Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) feedback to R&D during product development and transfer activities
Develop, review, and approve manufacturing documentation including work instructions, routings, process flow diagrams, PFMEAs, and control plans
Identify and implement process improvements to increase yield, reduce cycle time, and lower cost of goods
Lead and support process validation activities (IQ/OQ/PQ) in accordance with FDA and ISO requirements
Ensure changes to validated processes follow change control and risk management requirements
Collaborate with Quality to investigate nonconformances, deviations, and CAPAs using robust root cause analysis methodologies
Champion continuous improvement initiatives using Lean, Six Sigma, and other problem-solving methodologies
Analyze manufacturing data and metrics to identify trends, risks, and improvement opportunities
Support equipment upgrades, automation initiatives, and tooling improvements to enhance capacity, repeatability, and safety
Promote standardization and best practices across manufacturing lines and sites, where applicable
Lead, mentor, and develop a team of manufacturing engineers and technicians
Define staffing plans, assign priorities, and manage workloads to support production schedules and business objectives
Conduct hiring, onboarding, performance management, coaching, and development planning for direct reports
Work closely with Supply Chain and external suppliers to qualify materials, equipment, tooling, and contract services
Support supplier-related investigations and process improvements as needed
Collaborate with Program Management, R&D, and Quality to ensure smooth product launches and ongoing manufacturing performance
Develop and manage the manufacturing engineering budget, including capital equipment, tooling, and external services
Support long-term manufacturing strategy, capacity planning, and technology roadmap development
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline is required
Minimum of 5 years of experience in medical device manufacturing engineering, including people management or technical leadership experience
Strong understanding of medical device manufacturing processes and process validation requirements
Hands-on experience with catheter-specific manufacturing processes such as extrusion, braiding, bonding, coating, and assembly
Proficiency with manufacturing documentation systems and CAD tools (e.g., SolidWorks, AutoCAD)
Knowledge of GMP, GDP, and medical device regulatory requirements
Proficient with Microsoft Office and manufacturing data systems
Strong leadership presence in a production environment
Excellent problem-solving and root cause analysis skills
Ability to manage multiple priorities in a fast-paced manufacturing setting
Effective communication across all levels of the organization
Ability to influence cross-functional teams and drive change
Preferred
Master's degree is preferred
Prior experience in catheter manufacturing or complex disposable medical devices is strongly preferred
Experience in a contract manufacturing environment is highly desirable
Experience with Lean Manufacturing, Six Sigma, and statistical process control (SPC) methodologies preferred
Company
Zeus
Delivering dependable and innovative polymer solutions for over 50 years.
1001-5000 employees
H1B Sponsorship
Zeus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2023-12-18Acquired
Leadership Team
Steve Peterson
President & CEO
Scott Frost
VP, CIO
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