Back to jobs
tags.new

Senior Manufacturing Engineering Manager

Onsite in Wilmington, Massachusetts

About LightForce Orthodontics

LightForce Orthodontics is a 3D printing technology company focused on the orthodontic space. Our digital platform empowers orthodontists with fully customized, 3D-printed tooth-moving tools. In 2019, we launched their first product - the world’s only, fully customized 3D printed bracket system and digital treatment software. We are proud to be one of the fastest growing companies in the industry. Learn more at https://lf.co/

Description

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.

 

 

Create a Job Alert

Interested in building your career at LightForce Orthodontics? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in LightForce Orthodontics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.