About Us:
American Surgical Company is seeking an experienced and results-driven Manufacturing Engineer to join our Operations team. This hands-on role is responsible for developing, optimizing, and sustaining robust manufacturing processes within a regulated medical device environment. The Manufacturing Engineer will lead and support lean manufacturing initiatives that improve quality, throughput, and cost efficiency while reducing waste across production lines. This position also plays a critical role in new product introduction, partnering closely with R&D, Quality, and Production teams to ensure seamless design transfer, process scalability, and readiness for commercial manufacturing. The ideal candidate will bring strong technical expertise, demonstrated problem-solving abilities, and a track record of driving operational excellence through data-driven process improvements.
Position Summary
The Manufacturing Engineer will lead process improvements, support daily production needs, and play a key role in new product introduction. The ideal candidate is results-driven, technically strong, and experienced in driving operational excellence through data-based decision-making and lean methodologies.
Essential Duties and Responsibilities:
- Develop, optimize, and sustain manufacturing processes by creating, revising, and maintaining SOPs, work instructions, PFMEAs, and other controlled documentation in compliance with ISO 13485, FDA, and internal quality system requirements.
- Identify, evaluate, and implement automation and semi-automation solutions to improve manufacturing efficiency, quality, ergonomics, and scalability.
- Lead process improvement initiatives using lean manufacturing principles, structured problem-solving, and data-driven analysis to reduce waste, improve throughput, and enhance product quality.
- Plan, execute, and analyze time studies, workflow assessments, yield data, and process validation results to identify bottlenecks and drive continuous improvement.
- Serve as a primary technical resource on the production floor by providing hands-on troubleshooting support, resolving process issues, and ensuring process stability and robustness.
- Lead new product introduction activities, including design transfer, pilot builds, documentation preparation, risk assessments, and establishing process readiness for scale-up.
- Evaluate and improve manufacturing readiness through process capability analysis, labor planning, equipment requirements, material flow assessments, and production scalability initiatives
- Manage capital equipment projects, including evaluating technical solutions, coordinating vendor activities, supporting installation and qualification, and performing ROI and capacity analyses.
- Design, develop, and validate fixtures, jigs, and tooling to improve efficiency, ergonomics, consistency, and operator safety across manufacturing operations.
- Design and optimize manufacturing work cells, layouts, material flow, and operator workstations to improve productivity, ergonomics, and process consistency.
- Lead root cause investigations and drive corrective and preventive actions (CAPA) to closure, ensuring solutions are properly documented, verified, and sustained.
- Own and maintain controlled documentation and change control activities, including initiating and executing engineering change orders (ECOs).
- Support risk management activities by updating PFMEAs, enhancing process controls, and developing mitigation strategies throughout the product lifecycle.
- Provide training and technical guidance to production staff during the implementation of new processes, equipment, documentation updates, and NPI initiatives.
- Monitor, interpret, and report key manufacturing metrics including yield, scrap, cycle time, and downtime to support operational decision-making and continuous improvement.
- Support capacity planning activities through labor analysis, process evaluation, equipment utilization studies, and manufacturing readiness assessments.
- Communicate technical results, project status, and recommendations through clear engineering reports, presentations, and cross-functional updates.
Required Skills & Abilities
- Strong analytical and problem-solving abilities with a data-driven approach.
- Proficiency in lean manufacturing and continuous improvement methodologies.
- Skilled in creating clear, compliant technical documentation (SOPs, WIs, validations, etc.).
- Proficiency with CAD tools such as SolidWorks, DraftSight, or AutoCAD.
- Capable of working independently and collaboratively with cross-functional teams.
- Strong project management and organizational skills with the ability to manage multiple priorities.
- Experience with process validations, equipment qualifications, and change control in regulated environments.
- Hands-on approach with the ability to support daily production needs and implement fixture/tooling improvements.
Education & Experience
- Bachelor’s degree in Mechanical, Manufacturing, Industrial, Materials, Biomedical Engineering, or a related field.
- 3+ years of experience in manufacturing engineering, process engineering, industrial engineering, or a regulated manufacturing environment, preferably medical devices.
- Experience leading process improvements, troubleshooting production issues, and supporting daily manufacturing needs.
- Hands-on experience with process validations (IQ/OQ/PQ), equipment qualifications, and change control.
- Experience with new product introduction, design transfer, or scaling processes from prototype to production is strongly preferred.
- Familiarity with lean manufacturing principles and continuous improvement methodologies; formal training or certification is a plus.
- Experience developing or improving fixtures, tooling, or equipment to enhance manufacturing efficiency.
Physical Requirements & Work Environment:
- Ability to stand and walk for extended periods throughout the workday.
- Ability to work in both office and manufacturing environments.
- Ability to lift and move up to 25 pounds regularly and up to 50 pounds occasionally, with or without reasonable accommodation.
- Ability to perform hands-on evaluations, equipment troubleshooting, fixture installation, and process observations in a manufacturing environment.
- Ability to work in a cleanroom environment and comply with gowning requirements, including the use of hairnets, beard covers, gloves, smocks, and other required personal protective equipment (PPE).
- Ability to visually inspect products, equipment, and documentation with a high degree of accuracy.
Language Requirements
- Ability to read, understand, interpret, and create technical documentation in English.
- Ability to communicate technical information effectively in verbal and written English.
- Ability to develop and deliver training, procedures, reports, and engineering documentation in English.
- Proficiency in Spanish is a plus and may be beneficial for effective communication in a diverse manufacturing environment.
Job Type: Full-time
Pay: $85,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Vision insurance
Work Location: In person
