Senior Manufacturing Process Engineer

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

Job summary

A leading company is seeking a Senior Manufacturing Process Engineer in Saco, Maine, to develop and manage advanced optics assembly processes. The ideal candidate will have significant experience in precision manufacturing and a strong focus on continuous improvement in a collaborative environment.

Benefits

Health, dental, and vision insurance

Generous paid time off, including parental leave

401k with 4% company match, 100% vested

Flexible and professional work environment

Qualifications

• 5-10+ years in precision manufacturing, ideally with optics or medical devices.
• Proven experience developing manufacturing processes for optical components.
• Experience with ISO 13485 or ISO 9001 standards.

Responsibilities

• Develop and validate manufacturing processes for medical optical components.
• Lead new product introduction (NPI) efforts and troubleshoot manufacturing issues.
• Drive continuous improvement initiatives using Lean and Six Sigma.

Skills

Problem-solving

Communication

Initiative

Teamwork

Education

Bachelor's or Master's in Engineering

Tools

3D CAD (SolidWorks)

Quality document control systems

Job description

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FISBA NORTH AMERICA / SENIOR MANUFACTURING PROCESS ENGINEER / SACO, ME

We are working with our client, FISBA North America, in 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, Master Control, 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.

FISBA is an 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Manufacturing

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Inferred from the description for this job

Medical insurance

401(k)

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