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The Process Engineer – Quality Focus is responsible for developing, validating, controlling, and continuously improving manufacturing processes with an emphasis on process capability, product quality, and long-term process robustness within a regulated medical device manufacturing environment.

This role serves as the technical owner of injection molding and secondary manufacturing processes, ensuring processes are capable, compliant, sustainable, and aligned with internal quality standards, customer requirements, and regulatory expectations. The Process Engineer partners closely with Quality, Production, Tooling, Maintenance, Engineering, and Program Management teams to support daily manufacturing operations, new product introductions, and continuous improvement initiatives.

Essential Duties and Responsibilities

Process Ownership & Control

• Develop, establish, optimize, and maintain robust manufacturing processes for plastic injection molding and secondary operations.
• Serve as the process owner for assigned manufacturing cells and production lines.
• Define and maintain critical process parameters, validated process windows, and process control strategies to ensure consistent product quality and process stability.
• Monitor process performance utilizing SPC, capability analysis, and other statistical tools; respond appropriately to trends, variation, and out-of-control conditions.
• Troubleshoot molding and manufacturing process issues to improve efficiency, reduce variation, and minimize downtime.
• Support establishment of standard process settings, setup instructions, and manufacturing best practices.

Process Validation & Technical Documentation

• Lead and execute process validations including IQ, OQ, and PQ activities for new and existing products in compliance with applicable medical device regulations and internal procedures.
• Develop, review, and maintain technical manufacturing documentation including:
  • Process Flow Diagrams
  • Process FMEAs (pFMEAs)
  • Control Plans
  • Work Instructions and Setup Standards
  • Validation Protocols and Reports
• Ensure validation activities support long-term process capability and sustained manufacturing performance.
• Support change control activities related to materials, tooling, equipment, and process changes.

Quality & Compliance

• Partner closely with Quality Engineering to ensure manufacturing processes comply with ISO 13485, FDA Quality System Regulations, customer requirements, and internal quality standards.
• Support investigations and resolution activities related to:
  • Nonconformances
  • Deviations
  • CAPAs
  • Customer complaints
• Evaluate the impact of process, tooling, equipment, or material changes on validated states and product quality.
• Participate in internal, customer, and regulatory audits as a technical subject matter expert.

New Product Introduction (NPI)

• Support new product introduction activities from design transfer through production launch.
• Participate in design reviews and manufacturability assessments to ensure robust and capable manufacturing processes.
• Define manufacturing process requirements, equipment needs, tooling considerations, and validation strategies early in development.
• Collaborate cross-functionally to identify and mitigate manufacturing and process risks to support successful product launches.

Continuous Improvement

• Lead and support continuous improvement initiatives focused on:
  • Scrap and defect reduction
  • Yield improvement
  • Process capability enhancement (Cp/Cpk)
  • Cycle time optimization
  • Downtime reduction
• Utilize Lean Manufacturing, Six Sigma, DMAIC, 8D, and other structured problem-solving methodologies to improve operational and quality performance.
• Drive corrective and preventive actions that address true root causes and support sustainable process improvements.

Cross-Functional Collaboration & Training

• Collaborate with Production, Tooling, Maintenance, Quality, and Engineering teams to resolve technical manufacturing and quality issues.
• Provide technical guidance and process training to operators, technicians, inspectors, and other manufacturing personnel.
• Support development of standardized process practices and manufacturing documentation.
• Mentor junior engineers, technicians, or other team members as needed.

Qualifications

Education

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

Experience

• Minimum of 3–7 years of experience in manufacturing engineering, process engineering, or related technical roles.
• Experience in plastic injection molding and regulated manufacturing environments strongly preferred.
• Medical device manufacturing experience preferred.

Technical Knowledge & Skills

• Strong understanding of:
  • Plastic injection molding processes, tooling, and materials
  • Process validation methodologies (IQ/OQ/PQ)
  • Statistical Process Control (SPC) and process capability analysis
  • Process FMEAs and Control Plans
  • Root cause analysis and structured problem-solving methodologies
  • Lean Manufacturing and continuous improvement principles
• Working knowledge of ISO 13485 and FDA Quality System Regulations preferred.
• Experience with scientific molding principles is a plus.
• Proficiency with Microsoft Office and manufacturing/quality systems preferred.

Competencies

• Strong analytical, technical, and problem-solving skills.
• Data-driven decision-making mindset.
• Excellent written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to work effectively in a fast-paced manufacturing environment.
• Ability to manage multiple priorities and projects simultaneously.
• Comfortable spending significant time on the manufacturing floor.