Senior Manufacturing Engineering Manager

The Senior Manager, Manufacturing Engineering will lead the manufacturing engineering team responsible for all engineering activities on the production floor at LightForce Orthodontics. This role is critical in ensuring the efficient, high-quality production of our orthodontic products while driving continuous improvement initiatives and maintaining regulatory compliance. The position requires a hands-on leader who will own the sustainment and improvement of current manufacturing processes, oversee quality management systems (QMS), lead a dedicated quality team, and successfully transition new products from development into full-scale production.

Essential Duties & Responsibilities

• Lead and develop teams of manufacturing engineers and quality professionals responsible for production floor operations, quality assurance, process improvement, and new product introductions
• Build and manage a dedicated quality team responsible for maintaining the Quality Management System (QMS) and ensuring regulatory compliance
• Own the manufacturing process from initial process development through validation to sustained production with focus on quality excellence
• Lead the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with FDA, ISO 13485, and other relevant regulatory requirements
• Oversee internal and external quality audits, including preparation, execution, and corrective action implementation
• Drive continuous improvement initiatives to enhance production efficiency, quality, throughput, and cost reduction
• Ensure regulatory compliance throughout the manufacturing process and lead regulatory submissions related to manufacturing changes
• Collaborate with cross-functional teams including R&D, Quality, Regulatory Affairs, and Operations to ensure smooth transition of new products into production
• Develop and implement manufacturing processes, work instructions, standard operating procedures, and quality control protocols
• Lead CAPA (Corrective and Preventive Action) processes and quality investigations to drive systematic improvements
• Analyze production and quality data to identify trends, bottlenecks, and opportunities for process optimization
• Lead root cause analysis efforts to address production and quality issues and implement effective solutions
• Ensure manufacturing processes meet all quality requirements and regulatory standards
• Manage capital equipment selection, installation, qualification, and maintenance with appropriate quality controls
• Establish and manage technical relationships with key suppliers and manufacturing partners
• Lead technical supplier qualification, auditing, and performance management processes with emphasis on quality assurance
• Collaborate with procurement on supplier selection and development strategies
• Drive supplier quality improvement initiatives and ensure compliance with quality standards
• Lead technical troubleshooting and resolution of supplier quality issues
• Establish and track key performance indicators (KPIs) for manufacturing efficiency, quality metrics, and regulatory compliance

Education & Experience

• Bachelor's degree in Mechanical, Industrial, Manufacturing Engineering, Quality Engineering or related technical field; Master's degree preferred
• 8+ years of manufacturing engineering experience, with at least 5 years in a leadership role
• Experience in medical device manufacturing and quality management strongly preferred
• Experience leading quality teams and managing Quality Management Systems (QMS) in FDA-regulated environments
• Thorough understanding of medical device regulatory requirements (FDA, ISO 13485, EU MDR)
• Proven track record of implementing process improvements, quality systems, and cost reduction initiatives
• Experience with new product introductions and technology transfer to production
• Demonstrated experience managing technical aspects of supplier relationships and supplier quality programs

Required Qualifications

• Strong leadership skills with ability to build and develop high-performing manufacturing engineering teams in regulated environments
• Deep understanding of manufacturing processes, equipment, and production technologies including 3D printing, with proficiency in process validation and equipment qualification
• Experience implementing lean manufacturing methodologies with a data-driven approach to continuous improvement and complex problem-solving
• Demonstrated expertise in technical supplier management, including qualification, performance assessment, and driving compliance with quality standards
• Strong project management capabilities with ability to effectively manage multiple priorities in a fast-paced manufacturing environment
• Excellent cross-functional collaboration and communication skills with ability to work effectively across R&D, Quality, Operations, and external partners

Preferred Qualifications

• Knowledge of regulatory requirements for medical device manufacturing (FDA, ISO 13485, etc.)
• Experience with automated inspection and computer vision systems
• Experience managing complex technical supplier relationships in regulated industries
• Experience establishing and maintaining supplier quality agreements
• Knowledge of supplier development methodologies and best practices
• Lean Six Sigma certification (Green Belt or Black Belt)
• Experience implementing and managing MES (Manufacturing Execution Systems)

Physical Demands

• Regular presence on the manufacturing floor requiring prolonged standing, walking, and movement
• May require occasional lifting of equipment or materials up to 30 pounds
• Regular use of standard office equipment and manufacturing equipment
• May require occasional travel to vendor facilities and manufacturing partners

Perks and Benefits (US Employees Only)

• Unlimited PTO for exempt employees
• 10 paid holidays per year
• Generous premium coverage for medical, dental, and vision plans
• Group plan voluntary life insurance
• Fringe benefits
• 401k retirement plan
• Paid parental leave
• Allowances for those in commercial sales positions
• Workplace perks such as food/coffee

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liabilities.

LightForce Orthodontics is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.