Position Summary

We are seeking a highly technical, hands-on Mechanical Manufacturing Engineer to support New Product Introduction (NPI), manufacturing process development, product launches, and ongoing production operations within a growing medical device manufacturing environment.

This role is responsible for developing, implementing, and improving manufacturing processes, equipment, tooling, fixtures, and production methods to ensure products can be manufactured safely, efficiently, consistently, and at the required quality standards.

The Mechanical Manufacturing Engineer will work closely with Program Management, Product Development, Quality, Operations, Tooling, Maintenance, and Engineering to take products from initial development through production launch and to provide ongoing engineering support once products are in production.

A key responsibility of this position is to identify and solve manufacturing problems. The engineer will spend significant time on the manufacturing floor troubleshooting equipment, tooling, processes, fixtures, and production issues and developing practical, sustainable engineering solutions.

The ideal candidate is a hands-on mechanical engineer who enjoys working in a manufacturing environment, solving problems, developing equipment and tooling, supporting new product launches, and improving existing production processes.

Key Responsibilities

New Product Introduction (NPI) & Product Launch

• Provide manufacturing engineering support throughout the New Product Introduction process from development through production launch.
• Participate in Design for Manufacturability (DFM) and Design for Assembly (DFA) reviews.
• Evaluate product designs for manufacturability, assembly, tooling, equipment, and production requirements.
• Identify manufacturing risks and recommend design or process improvements.
• Develop manufacturing processes, equipment, tooling, fixtures, and production methods required for new products.
• Support prototype, engineering, pilot, and production builds.
• Work with Program Management and cross-functional teams to identify and resolve launch issues.
• Support development of manufacturing documentation, process requirements, work instructions, and engineering specifications.
• Ensure manufacturing processes and equipment are ready for production launch.
• Support production ramp-up and stabilization following launch.
• Identify opportunities to improve manufacturability, quality, throughput, and cost before and after product launch.

Mechanical Engineering & Manufacturing Equipment

• Design, develop, modify, and implement manufacturing equipment, fixtures, tooling, jigs, gauges, and production aids.
• Develop mechanical solutions to improve production processes and product quality.
• Create and maintain mechanical drawings, specifications, layouts, and engineering documentation.
• Select appropriate mechanical components, materials, mechanisms, and equipment for manufacturing applications.
• Develop prototypes and test mechanical concepts prior to production implementation.
• Work with internal teams and outside suppliers to develop custom equipment and tooling.
• Support equipment installation, setup, troubleshooting, commissioning, and production startup.
• Evaluate existing manufacturing equipment and identify opportunities to improve reliability, efficiency, ergonomics, and safety.
• Support the development and implementation of automated and semi-automated manufacturing equipment.

Current Production Support & Troubleshooting

• Serve as a technical engineering resource for ongoing manufacturing operations.
• Troubleshoot mechanical, equipment, tooling, fixture, process, and production issues.
• Work directly with operators, technicians, supervisors, and engineers to identify problems and develop solutions.
• Investigate recurring production issues and determine root causes.
• Develop and implement corrective actions that provide sustainable, long-term solutions.
• Respond to production issues that impact quality, throughput, downtime, scrap, or delivery.
• Analyze production data and process information to identify trends and improvement opportunities.
• Support equipment breakdowns and process interruptions when engineering assistance is required.
• Develop modifications to equipment, tooling, fixtures, and processes to resolve production problems.
• Provide technical support during production trials, engineering builds, and process changes.

Tooling & Fixtures

• Design and develop production tooling, fixtures, gauges, workholding devices, and mechanical aids.
• Partner with Tooling to develop, troubleshoot, and improve molds and manufacturing tooling.
• Develop fixtures that improve part positioning, assembly, inspection, repeatability, and operator ergonomics.
• Troubleshoot tooling-related production issues and identify engineering improvements.
• Work with tooling suppliers and internal toolmakers on new and modified tooling.
• Support mold trials and tooling qualification activities.
• Evaluate tooling performance and identify opportunities to improve reliability, quality, and cycle time.

Manufacturing Process Development

• Develop and improve manufacturing processes from initial concept through production.
• Evaluate manufacturing methods, equipment, tooling, labor requirements, and process flow.
• Develop manufacturing cells and workstations that optimize efficiency, quality, ergonomics, and material flow.
• Conduct cycle-time studies, time studies, capacity assessments, and process evaluations.
• Identify opportunities to reduce scrap, defects, downtime, labor, and manufacturing costs.
• Implement mistake-proofing, poka-yoke, error detection, and process control solutions.
• Develop and implement process improvements based on engineering analysis and production data.
• Standardize successful manufacturing processes and engineering solutions.

Injection Molding & Plastics Manufacturing

• Support injection molding process development, troubleshooting, and optimization.
• Work with Process Engineering and Tooling to troubleshoot mold, machine, material, and process issues.
• Support mold trials, engineering trials, and production ramp-up activities.
• Identify opportunities to improve cycle time, scrap, yield, process consistency, and equipment performance.
• Apply mechanical and manufacturing engineering principles to injection molding and downstream manufacturing processes.
• Support scientific molding and process characterization activities as needed.

Automation & Equipment Integration

• Work collaboratively with Automation Engineering and other technical resources to develop and implement manufacturing solutions.
• Provide mechanical engineering support for automated and semi-automated equipment.
• Develop mechanical components, tooling, fixtures, product handling systems, and equipment interfaces.
• Support equipment integration, debugging, installation, and production startup.
• Identify opportunities to automate manual processes and improve consistency, throughput, ergonomics, and labor efficiency.
• Support evaluation and implementation of new manufacturing technologies.

Validation & Regulated Manufacturing

• Support equipment and process validation activities, including IQ/OQ/PQ.
• Support development of equipment specifications, qualification requirements, and validation documentation.
• Ensure manufacturing engineering activities comply with applicable ISO 13485, FDA, GMP, and customer requirements.
• Support Engineering Change Orders and implementation of manufacturing changes.
• Partner with Quality on CAPA, nonconformance investigations, root cause analysis, and corrective actions.
• Maintain appropriate engineering documentation for equipment, tooling, processes, and manufacturing changes.

Transfer of Business

• Support the transfer of products, tooling, equipment, and manufacturing processes from sister facilities or external suppliers.
• Evaluate manufacturing requirements for transferred products.
• Support replication and improvement of manufacturing processes.
• Identify equipment, tooling, fixture, and process requirements associated with transferred business.
• Support equipment installation, startup, qualification, and production ramp-up.
• Troubleshoot and stabilize transferred processes during implementation.

Continuous Improvement

• Identify and implement engineering improvements to existing manufacturing processes.
• Drive improvements in:
  • Throughput
  • Cycle time
  • Scrap
  • Yield
  • Equipment uptime
  • OEE
  • Labor efficiency
  • Process capability
  • Ergonomics
  • Manufacturing cost
• Utilize Lean Manufacturing and structured problem-solving methodologies.
• Conduct root cause analysis and implement sustainable corrective actions.
• Evaluate opportunities for equipment modifications, tooling improvements, process changes, and automation.
• Continuously improve the reliability and capability of manufacturing processes.

Supplier & Technical Support

• Work with equipment manufacturers, tooling suppliers, automation integrators, and other technical vendors.
• Develop technical requirements and specifications for equipment and tooling.
• Review supplier designs and provide engineering feedback.
• Support equipment and tooling design reviews, testing, installation, and commissioning.
• Troubleshoot technical issues with suppliers and external partners.
• Ensure purchased equipment and tooling meet manufacturing requirements.

Qualifications

Education

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Mechanical Engineering Technology, or related engineering discipline required.
• Plastics Engineering or related discipline preferred.

Experience

• 3+ years of experience in mechanical engineering, manufacturing engineering, or a related production engineering role.
• Experience working directly in a manufacturing environment.
• Experience with manufacturing equipment, tooling, fixtures, or process development.
• Experience supporting NPI through production launch preferred.
• Experience troubleshooting current production processes and equipment.
• Injection molding or plastics manufacturing experience strongly preferred.
• Medical device or other regulated manufacturing experience preferred.
• Experience working with automated or semi-automated manufacturing equipment preferred.