Location: On‑site
Employment Type: Full‑Time
Job Overview
We are seeking an experienced Manufacturing Engineer to lead advanced engineering initiatives that enhance manufacturing processes, improve production efficiency, and ensure compliance with quality and regulatory standards. This role is hands‑on and highly collaborative, supporting multiple product lines in a regulated manufacturing environment.
The ideal candidate brings strong technical expertise in process validation, statistical analysis, plastics manufacturing, and lean principles, along with the ability to influence cross‑functional teams and drive measurable improvements.
What You’ll Do
- Lead and execute advanced process and equipment validations (IQ, OQ, PQ, PV), including development of validation protocols and reports.
- Drive process automation initiatives to improve efficiency, consistency, and throughput.
- Support and optimize injection molding and extrusion processes, tooling, and equipment across multiple product lines.
- Implement and sustain Statistical Process Control (SPC) practices to monitor and improve process capability.
- Perform advanced data analysis including PFMEA, ANOVA, capability studies, and other statistical evaluations.
- Develop and maintain Process Control Plans in compliance with ISO 13485 and FDA regulations.
- Investigate and resolve product complaints and manufacturing issues using structured root cause analysis.
- Mentor teams on lean manufacturing principles and lead lean improvement events to reduce waste and improve productivity.
- Collaborate with design and R&D teams to ensure manufacturability and lead successful design transfers to production.
- Define and implement sampling plans to support quality and testing efficiency.
- Interface with customers on technical topics including process changes and validation activities.
- Present manufacturing and quality metrics (Preventive Maintenance, First Pass Yield, Calibration) at management reviews.
- Develop systems to track production yields, efficiency, and labor utilization.
- Ensure compliance with safety, quality, and OSHA standards.
- Identify opportunities to reduce costs and improve throughput while maintaining product quality.
What We’re Looking For
- Bachelor’s degree in Mechanical, Chemical, or related Engineering field (Master’s preferred).
- 5+ years of manufacturing engineering experience in medical devices, pharmaceuticals, or chemical manufacturing.
- 3+ years of hands‑on experience with plastics injection molding; extrusion experience strongly preferred.
- Proven experience leading validation activities in FDA‑regulated environments.
- Proficiency with statistical tools (e.g., Minitab) and advanced data analysis techniques.
- Strong working knowledge of lean manufacturing tools and methodologies.
- Solid understanding of production scheduling, run rates, cycle times, and equipment changeovers.
- Advanced proficiency in Microsoft Excel, Word, and PowerPoint.
- Demonstrated ability to lead projects and influence cross‑functional teams.
- Strong communication, analytical, and problem‑solving skills.
- Highly organized, results‑driven, and able to manage multiple priorities.
- Commitment to ethical practices, safety, and collaboration.
Physical & Work Environment Requirements
- Regularly required to stand, walk, and use hands to operate equipment or computers.
- Occasionally required to lift or move items up to 25 pounds.
- Work environment includes exposure to manufacturing floor conditions.
Key Competencies
- Leadership & Strategic Thinking
- Advanced Problem‑Solving & Decision‑Making
- Project Management
- Cross‑Functional Collaboration
- Innovation & Continuous Improvement
- Compliance Leadership
- Metrics‑Driven Performance
Why Join Us?
- You’ll have the opportunity to make a direct impact on manufacturing performance, quality, and innovation while working in a collaborative, technically advanced environment that values continuous improvement and operational excellence.
