KMA Human Resources Consulting
Senior Manufacturing Process Engineer
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.
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.