Sr. Manufacturing Process Engineer
About The Position
As a Senior Manufacturing Process Engineer, you will provide technical leadership in developing, optimizing, and scaling manufacturing processes for orthodontic device production. You will drive process efficiency, quality, and compliance; lead cross-functional improvement initiatives; support production planning through capacity management and manufacturing readiness reviews; and mentor engineering teams. You will work closely with Operations, Quality, Supply Chain, Product Development, and Site Leadership to align manufacturing performance with business objectives, innovation, operational excellence, and long-term growth strategies. The role is considered a deep expert in orthodontics, with broad knowledge of related fields. It includes improving existing processes, supporting manufacturability of new products, designing compliant manufacturing processes, resolving production issues, and maintaining process documentation. You will also lead complex manufacturing projects and capacity reviews, develop manufacturing strategies and technology roadmaps, and mentor Process Engineers and Manufacturing Technicians.
Requirements
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related field.
- At least 3 years of experience in manufacturing process engineering and GMP.
- At least 2 years of experience with CAD/CAM software and knowledge of design for manufacturability principles.
- At least 1 year of experience with regulatory requirements and quality standards relevant to orthodontic device manufacturing, such as FDA regulations or ISO 13485.
Nice To Haves
- An advanced degree.
- Manufacturing process knowledge specific to orthodontic devices, including assembly, machining, molding, and finishing.
- Experience with photopolymer additive manufacturing, including DLP, SLA, or other additive manufacturing processes.
- Proficiency in lean manufacturing principles, process optimization techniques, and statistical analysis tools.
- Understanding of Six Sigma tools and methods, including fishbone diagrams, 5 Whys, PFMEA, SPC, root cause analysis, and lean manufacturing.
- Attention to detail and a focus on quality and continuous improvement.
- Strong problem-solving skills and the ability to analyze complex manufacturing issues.
- Strong communication and collaboration skills for working effectively with cross-functional teams.
Responsibilities
- Evaluate existing manufacturing processes and identify opportunities to improve productivity, cost-effectiveness, and quality.
- Develop and implement process improvements to enhance product quality, reduce waste, and increase efficiency.
- Collaborate with product development teams on the manufacturability of new orthodontic products, including design for manufacturability principles.
- Design and develop manufacturing processes, including assembly, machining, molding, and finishing, in compliance with regulatory and quality standards.
- Conduct time studies, capacity analysis, and line balancing to optimize production flow and throughput.
- Provide technical support and troubleshoot manufacturing issues with production personnel to resolve problems and minimize downtime.
- Apply lean manufacturing principles and continuous improvement initiatives.
- Develop and maintain work instructions, standard operating procedures, and other documentation for process consistency and compliance.
- Collaborate with Quality Assurance on process validation protocols and statistical process control analysis.
- Stay current on orthodontic manufacturing industry trends, technological advancements, and best practices.
- Lead manufacturing capacity reviews and production-readiness planning with Operations and Supply Chain to ensure adequate resources, equipment utilization, and long-term manufacturing capability.
- Facilitate cross-functional engineering meetings and align Manufacturing, Quality, Operations, Maintenance, and Product Development teams to resolve technical challenges and support strategic objectives.
- Provide technical leadership and mentorship to Process Engineers and Manufacturing Technicians, promoting best practices, problem-solving methods, and continued development of engineering capabilities.
- Lead complex manufacturing projects and site-wide improvement initiatives, managing timelines, risks, stakeholder communications, and implementation.
- Develop manufacturing strategies and technology roadmaps to support future growth, automation opportunities, and operational excellence.
- Perform other related duties and responsibilities as assigned.
- Stay current with material removal, inspection, and manufacturing system technologies and philosophies.
Benefits
- 401(k) plan with employer match.
- Health, dental, and vision insurance, with the company contributing toward employee premiums.
- Generous paid time off.
- Competitive total compensation plans.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
