Senior Manufacturing Process Engineer

KMA Human Resources Consulting LLC; Saco (ME); On-site; USD 100,000 - 120,000; Full time

Job summary

A leading company dedicated to optical solutions is seeking a Senior Manufacturing Process Engineer for their Saco, ME facility. The ideal candidate will develop and manage manufacturing processes related to precision medical optical components, ensuring compliance with industry standards and contributing to continuous improvement efforts. Join a fast-paced, collaborative environment that values growth and innovation.

Benefits

100% employer-paid health, dental, and vision insurance

Generous paid time off, including parental leave

401k with 4% company match

Flexible and professional work environment

Qualifications

• 5-10+ years in precision manufacturing, ideally optics or medical devices.
• Proven experience developing, validating, and improving manufacturing processes for optical components.
• Strong experience with NPI, DFM, and pFMEA.

Responsibilities

• Develop, optimize, and validate manufacturing processes for precision medical optical components.
• Lead new product introduction efforts and troubleshoot complex manufacturing issues.
• Drive continuous improvement initiatives using methodologies like Lean and Six Sigma.

Skills

Problem Solving

Communication

Project Management

Education

Bachelor's or Master's in Engineering

Tools

3D CAD (SolidWorks)

ISO 13485

Job description

FISBA NORTH AMERICA /SENIOR MANUFACTURINGPROCESS ENGINEER / SACO, ME

FISBA North America is seeking a SENIOR MANUFACTURING PROCESS ENGINEER to work from their Saco, Maine office/production facility.

The position reports to the Director of Engineering and Production to develop and manage production processes related to advanced optics assemblies and systems for the biomedical and life sciences markets. The ideal candidate will be self-motivated, detail-oriented, and eager to shape and expand the role as the company evolves.

US Citizen or Green Card holders Only

Pay and Benefits:

• Salary range starts at $100k commensurate with experience
• Health, dental, and vision insurance: 100% employer paid for employee coverage with company HSA contribution
• STD, LTD and Life
• Generous paid time off, including parental leave
• 401k with 4% company match; 100% vested
• Flexible and professional work environment

Requirements of the Position:

• Bachelor's or Master's in Engineering (Mechanical, Optical, Manufacturing preferred) or equivalent hands-on experience, with 5-10+ years in precision manufacturing, ideally with optics or medical devices
• Proven experience developing, validating (IQ/OQ/PQ), and improving manufacturing processes for optical components/assemblies
• Strong experience with New Product Introduction (NPI), Design for Manufacturability (DFM), and pFMEA
• Proficiency with ISO 13485 (medical devices) or ISO 9001 standards
• Experience working within a formal quality document control system (e.g., Agile, Arena, MasterControl, or similar)
• Experience with 3D CAD (e.g., SolidWorks) and applying GD&T is a plus
• Demonstrated problem-solving skills and experience leading CAPAs
• Proven ability to work independently, take initiative, and manage priorities effectively with minimal supervision
• Excellent communication and ability to work in cross-functional teams

Responsibilities of the Position:

• Develop, optimize, and validate manufacturing processes for precision medical optical components and devices
• Lead new product introduction (NPI) efforts, ensuring designs are optimized for manufacturability (DFM)
• Troubleshoot complex manufacturing issues and implement effective corrective/preventive actions (CAPA)
• Specify, procure, and validate manufacturing equipment, tooling, and fixtures for optical production
• Ensure manufacturing processes comply with medical device regulations (e.g., FDA QSR, ISO 13485)
• Drive continuous improvement initiatives (yield, cost, efficiency) using methodologies like Lean and Six Sigma
• Provide technical leadership and mentorship in optical product manufacturing

FISBA is a global company dedicated to developing optical solutions for Life Sciences, Advanced Manufacturing and Aerospace and Defense applications. FISBA North America, based in Saco Maine, specializes in the design and manufacturing of medical endoscopes and life science applications. As a growing division within FISBA’s global operation, FISBA North America’s culture is fast paced, collaborative and supportive. Our team offers a unique opportunity to join a small team within a larger organization, focused on building a high-precision engineering and manufacturing company.

Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, familial status, age, physical or mental disability, pregnancy, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected by law.