Manufacturing Engineer
Listed on 2025-12-21
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Manufacturing / Production
Manufacturing Engineer, Quality Engineering
Zest Dental Solutions provided pay range
This range is provided by Zest Dental Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range$85,000.00/yr - $/yr
Additional compensation typesAnnual Bonus
The Manufacturing Engineer I supports the medical device manufacturing process.
EssentialJob Duties and Responsibilities
- Provide hands‑on support on the production floor by troubleshooting manufacturing equipment, resolving process issues, and ensuring production lines run efficiently and safely.
- Collaborate with the operations team to optimize workflows, implement process improvements, and support day‑to‑day production needs to maintain product quality and compliance with medical device standards.
- Develop, document and optimize manufacturing processes and operating procedures within a regulated quality system utilizing lean manufacturing principles.
- Ensure all projects/processes are in compliance with FDA, Current Good Manufacturing Practices (cGMP), Quality System Requirement (QSR), ISO‑13485 and other applicable requirements.
- Write, review and approve validations (IQ/OQ/PQ protocols), Standard Operating Procedures (SOP), technical reports and final reports for new products, processes, and equipment.
- Assist in identification and implementation of advanced manufacturing technologies and make recommendations for process requirements of new or existing product lines.
- Assist in the review and evaluation of capacity models and anticipate when new equipment or additional headcount will be required.
- Evaluate technical problems and drive down to root causes in order to implement sustainable resolutions.
- Train manufacturing personnel.
- BS Degree in Engineering with specific experience in working in a medical device and/or biopharma manufacturing environment.
- Minimum 1 year of experience in an engineering function dealing with processes and equipment in a cGMP/FDA/ISO manufacturing environment.
- Proven experience including process documentation, IQ/OQ/PQ protocols and reporting.
- Hands‑on experience working on the production floor, including troubleshooting manufacturing equipment, supporting operators, and resolving real‑time process issues.
- Experience with batch mixing, bottle filling and packaging equipment a plus.
- A proven self‑starter with the ability to identify areas of improvement and/or need and act accordingly to produce objective results.
- Excellent communication, organizational and time‑management skills; ability to pay close attention to detail. Ability to work as part of a team and drive completion of action items.
- Flexibility to change direction frequently and with little notice.
- Ability to manage multiple priorities and tasks and projects.
- Strong problem solving and analytical skills.
- Ability to sit, use hands and fingers, talk or hear, and smell continually. Ability to stand, walk and reach frequently. Ability to climb or balance, stoop, kneel, or crouch occasionally.
- Ability to frequently lift and carry up to 10 lbs. and occasionally lift and carry up to 25 lbs.
- Close vision required to use microscope, read documents, and operate machine. Distance vision required to drive an automobile, if driving is a requirement of the job.
- Work environment is indoors and climate controlled. Occasionally exposed to outdoor weather conditions.
- Moderate noise levels as found in a light industrial environment, office environment, households with TVs and dishwashers, and driving light traffic.
The above job description is intended to describe the content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Zest Dental Solutions reserves the right to change, add, or delete at any time from this job description to meet the needs of the Company.
Seniority level: Associate
Employment type: Full‑time
Job function: Manufacturing, Engineering, and Quality Assurance
Industry: Medical Equipment Manufacturing
Benefits- Medical insurance
- Vision insurance
- 401(k)
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