Engineering Manager

Position Summary

We are seeking a highly technical, hands-on, and strategic Engineering Manager to lead the engineering function within a growing Injection Molding Center of Excellence focused primarily on medical device manufacturing.

The Engineering Manager is responsible for leading Manufacturing Engineering, Process Engineering, automation support, and NPI engineering execution to ensure successful product launches, robust manufacturing processes, technical capability, and long-term scalability.

This role serves as the technical owner of manufacturing process development, process capability, engineering standards, and technical solutions across the Center of Excellence. The Engineering Manager will lead the development of robust, repeatable, and highly capable manufacturing processes that consistently produce high-quality parts with minimal variation while supporting customer requirements, operational performance, and future business growth.

The Engineering Manager will partner closely with Operations, Quality, Tooling, Program Management, Customers, Commercial, Finance, and Human Resources to support product development, new product introduction, transfer of business, process validation, automation implementation, capacity expansion, and continuous improvement.

The ideal candidate is a highly collaborative engineering leader with deep injection molding expertise, strong scientific molding knowledge, hands-on technical capability, and a proven track record of developing and scaling manufacturing processes within regulated environments.

As a key member of the Senior Leadership Team, this role will help establish the technical strategy and engineering capabilities required to support the Center of Excellence's continued growth, customer confidence, operational scalability, and long-term competitiveness.

Key Responsibilities

Engineering Leadership & Technical Strategy

• Lead and develop the Manufacturing Engineering, Process Engineering, and engineering support teams.
• Establish Engineering as the technical owner of manufacturing process development, process capability, engineering standards, and technical solutions across the Center of Excellence.
• Build a high-performing engineering organization focused on technical excellence, accountability, process control, innovation, and continuous improvement.
• Establish engineering standards, best practices, methodologies, and scalable manufacturing systems.
• Develop and maintain engineering processes that support consistent execution across programs, manufacturing cells, and product families.
• Align engineering priorities with business objectives, customer requirements, operational needs, quality expectations, and long-term growth plans.
• Develop engineering talent, technical capability, succession plans, and career development within the organization.
• Provide technical leadership and mentorship to engineers and cross-functional teams.

New Product Introduction (NPI) & Product Launch

• Provide engineering leadership for New Product Introduction, product transfers, and manufacturing launches.
• Partner closely with Program Management, Customers, Quality, Tooling, and Operations to ensure successful launch execution.
• Lead Design for Manufacturability (DFM) reviews and manufacturing feasibility assessments.
• Evaluate product, tooling, equipment, process, and automation requirements during the development and launch process.
• Develop manufacturing strategies that support quality, process capability, scalability, throughput, and cost objectives.
• Establish technical readiness requirements for new product launches, including tooling, equipment, process development, validation, documentation, and training requirements.
• Drive engineering timelines, technical deliverables, risk identification, and mitigation throughout launch activities.
• Ensure successful technical handoff of new products and processes into production.

Process Engineering & Scientific Molding

• Lead development and optimization of injection molding processes using scientific molding principles and data-driven methodologies.
• Partner closely with Process Engineers and Manufacturing Engineers to establish robust, repeatable, and highly capable processes.
• Establish standardized methodologies for process development, process characterization, and process documentation.
• Drive development of process windows, capability studies, DOE activities, and process optimization.
• Establish engineering standards focused on:
  • Process repeatability and stability
  • Process capability and consistency
  • Scrap and defect reduction
  • Cycle optimization
  • Quality and yield improvement
  • Process reliability
  • Long-term manufacturability and scalability
• Lead technical troubleshooting of complex molding, tooling, automation, equipment, and manufacturing challenges.
• Apply structured problem-solving and root cause analysis to address technical issues and prevent recurrence.
• Partner with Quality and Operations to ensure process improvements are sustained in production.

Tooling, Automation & Manufacturing Technology

• Partner closely with Tooling leadership to integrate mold design, tooling capability, process requirements, and production needs throughout NPI and ongoing manufacturing.
• Provide engineering leadership for tooling trials, mold/process development, and technical troubleshooting.
• Support the evaluation, development, and implementation of automation and advanced manufacturing technologies.
• Ensure automation solutions are technically capable, reliable, scalable, and aligned with manufacturing requirements.
• Partner with Operations to transition new technology and automation into sustainable production.
• Evaluate emerging technologies that can improve quality, productivity, process capability, and manufacturing scalability.

Validation & Regulated Manufacturing

• Lead engineering support for process validation activities, including IQ/OQ/PQ execution.
• Develop and execute validation strategies for new products, transferred programs, equipment, and significant process changes.
• Ensure manufacturing processes and engineering activities support ISO 13485, FDA, GMP, and customer-specific requirements.
• Partner closely with Quality on validation protocols, reports, risk assessments, CAPA investigations, root cause analysis, and process improvements.
• Ensure engineering documentation, protocols, specifications, and change controls meet regulatory and customer requirements.
• Support audit readiness and customer or regulatory audits involving engineering processes and technical capabilities.

Manufacturing Engineering & Technical Operational Support

• Lead engineering-driven improvements that enhance process capability, productivity, reliability, manufacturability, and technical scalability.
• Partner with Operations to improve manufacturing performance through engineering solutions, process optimization, automation, and equipment improvements.
• Provide technical support for complex manufacturing issues and recurring production problems.
• Support capital equipment planning, technical specifications, installation, qualification, and startup.
• Evaluate technical solutions that improve productivity, manufacturability, quality, and cost performance.
• Provide engineering expertise during major equipment, tooling, process, and manufacturing changes.
• Establish technical systems and standards that enable consistent manufacturing execution as the business grows.

Transfer of Business & Capacity Expansion

• Lead engineering activities related to the transfer of products, tooling, equipment, and manufacturing processes from sister sites or external suppliers.
• Develop technical transfer plans to ensure successful replication of processes and manufacturing capability.
• Lead process trials, technical assessments, process characterization, validation, and ramp-up activities associated with transfers.
• Partner with Operations to ensure transferred processes are successfully integrated into production.
• Support equipment and tooling installation, startup, qualification, and technical readiness.
• Develop scalable engineering systems and manufacturing processes capable of supporting significant business growth.
• Identify technical capacity constraints and develop engineering solutions to support future demand.

Customer Engagement & Technical Support

• Participate in customer meetings, technical reviews, audits, site visits, and manufacturing discussions.
• Provide technical leadership and engineering expertise during customer interactions.
• Support quoting and feasibility reviews for new business opportunities.
• Evaluate technical requirements, tooling needs, process complexity, automation opportunities, and manufacturing risks.
• Build customer confidence through strong technical execution, disciplined engineering processes, and reliable manufacturing solutions.
• Partner with Commercial and Program Management teams to support growth opportunities and customer commitments.

Continuous Improvement & Technical Excellence

• Lead engineering-driven continuous improvement initiatives focused on:
  • Process capability
  • Scrap and defect reduction
  • Cycle optimization
  • Yield improvement
  • Process reliability
  • Automation
  • Manufacturability
  • Technical scalability
• Establish a culture of structured problem-solving, data-driven decision-making, and technical excellence.
• Standardize engineering practices, methodologies, documentation, and lessons learned across programs and manufacturing cells.
• Identify opportunities to leverage technology, automation, process improvements, and engineering systems to support future growth.
• Partner with Operations and Quality to ensure engineering improvements translate into sustained manufacturing performance.

Financial & Business Contribution

• Support engineering operating and capital budgets.
• Develop technical recommendations and business cases for capital equipment, automation, tooling, and manufacturing technology investments.
• Evaluate engineering investments based on quality, capacity, productivity, scalability, customer requirements, and financial return.
• Support capacity planning and long-term manufacturing technology strategies.
• Develop engineering capabilities and scalable manufacturing processes that support planned business growth of approximately $3–5 million annually while maintaining quality, delivery, and cost performance.
• Contribute to overall business growth, customer retention, operational scalability, and profitability through strong technical execution.

People Leadership & Organizational Development

• Lead, coach, and develop the engineering organization.
• Establish clear performance expectations, accountability, and development plans for engineering team members.
• Build technical depth and organizational capability to support future business growth.
• Develop succession plans and identify opportunities for internal talent development.
• Foster a collaborative environment between Engineering, Operations, Quality, Tooling, Program Management, and other functional teams.
• Promote a culture of ownership, accountability, continuous learning, and technical excellence.

Qualifications

Education

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

Experience

• 8+ years of progressive engineering experience, including significant engineering leadership responsibility within injection molding, medical device manufacturing, plastics, or another highly regulated manufacturing environment.
• Proven experience leading engineering teams in complex manufacturing environments.
• Strong injection molding and scientific molding experience.
• Strong experience with:
  • Process development and optimization
  • Scientific molding
  • New Product Introduction (NPI)
  • Design for Manufacturability (DFM)
  • IQ/OQ/PQ validation
  • Injection molding troubleshooting
  • Process characterization and capability
  • Manufacturing transfers
  • Automation integration
  • Manufacturing process scaling
• Experience supporting medical device manufacturing strongly preferred.
• Experience with cleanroom manufacturing and regulated production environments preferred.
• Demonstrated experience developing and implementing scalable manufacturing processes.
• Experience working directly with customers and cross-functional leadership teams preferred.

Technical & Leadership Competencies

Technical Expertise

• Deep expertise in injection molding process development and scientific molding methodologies.
• Strong understanding of tooling, mold design, automation, process validation, and manufacturing systems.
• Strong understanding of process capability, process characterization, DOE, and statistical problem-solving.
• Knowledge of ISO 13485, FDA, GMP, and regulated manufacturing requirements.
• Strong technical troubleshooting and root cause analysis skills.
• Ability to evaluate complex technical issues and develop practical, sustainable manufacturing solutions.

Engineering Leadership

• Proven ability to build, lead, and develop high-performing engineering teams.
• Ability to establish engineering standards, systems, and technical disciplines across an organization.
• Strong technical judgment and decision-making capability.
• Ability to balance hands-on technical involvement with strategic engineering leadership.
• Demonstrated ability to develop engineering talent and build organizational capability.