Tooling Engineer II

About the role

Your excellent problem-solving skills, attention to detail, and the ability to manage multiple projects efficiently are crucial for contributing to the overall efficiency and effectiveness of production operations by ensuring that the right tools are designed, developed, and maintained.

Responsibilities

• Coordinate directly with customers to develop and commercialize products.
• Develop extrusion processes while considering proper equipment size, screw type, draw down ratios, and downstream equipment for a wide range of polymers.
• Perform statistical analysis and utilize results to develop robust processes.
• Develop protocols, test methods, and reports for execution of verification and validation activities.
• Design and implement tooling for new extruded products as well as related equipment throughout the production environment.
• Independently utilize all equipment in the extrusion process and instruct others on proper use as well.
• Provide equipment/tooling vendors with all documentation and sample components required to design, fabricate, troubleshoot, and accept equipment/tooling.
• Plan and coordinate the selection, procurement, installation, start-up, and qualification of new capital equipment, tooling, and fixtures for medical device manufacturing IQ/OQ.
• Develop and drive project plans by identifying tasks, resource requirements, timelines, and Cap Ex/expense budgets and provide status updates as required.
• Supports requests for quotes by outlining necessary project activities and timing for new product introduction.

Requirements

• Bachelor’s degree (BA/BS) in Mechanical Engineering, Chemical Engineering, Materials Science, or a related field preferred.
• A minimum of three (3) years of experience in medical device manufacturing and/or extrusion or molding processes is required.
• Experience with CNC fabrication and machining processes is a plus, but not required.
• Hands-on, team-oriented approach with a strong commitment to supporting production operations.
• Solid understanding of plastic materials and extrusion processing techniques.
• Strong interpersonal and communication skills; able to effectively collaborate with employees at all organizational levels.
• Proficient in documentation practices; familiarity with ISO 13485 standards preferred.
• Proficiency in Microsoft Office, CAD software, and Minitab.
• Ability to evaluate and research plastic materials for specific applications.
• Able to interpret customer requirements and translate them into technical solutions.

Physical Demands and Work Environment

• Regularly work in office space as well as in the production environment.
• Must wear all required Personal Protective Equipment (PPE) in production area.
• Occasionally lift up to 30 lbs. for short durations (1 minute or less).
• May stand for periods of up to 5 consecutive hours.
• May sit for periods of up to 3 consecutive hours.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Basic and optional voluntary life insurance.
• Short- and long-term disability coverage.
• Employee Assistance Program (EAP).
• 401(k) retirement plan with employer contributions.
• Generous vacation and personal time off (PTO).