Principal Manufacturing Engineer

The Principal Manufacturing Engineer is a hands‑on technical leader responsible for new product introduction and for defining, validating, and sustaining robust manufacturing processes for electromechanical medical devices. This role supports the development and execution of manufacturing and validation strategies, authors core validation documentation, and collaborates closely with Quality, R&D, Supply Chain, and external manufacturing partners to ensure compliant and scalable production processes. Working knowledge and experience with the processes associated with single use devices (adhesive bonding, thermal welding, injection molding and extrusion) would be considered a strong plus. Primary Responsibilities Lead development and execution of manufacturing, test, and validation strategies aligned with regulatory requirements, product risk, and business objectives. Serve as a technical authority for manufacturing process development and validation of electromechanical products. Develop and maintain Master Validation Plans (MVPs) covering equipment, processes, software, and test methods. Lead test method validation (TMV) activities including test strategy development, Gage R&R, robustness studies, and statistical justification of acceptance criteria. Ensure all validation activities comply with FDA, ISO 13485, and applicable regulatory standards. Apply statistical methods (DOE, Cp/Cpk, MSA) to process characterization, validation, and troubleshooting. Analyze data trends to establish control strategies and drive continuous process improvements. Author and review technical documentation including validation plans, reports, protocols, work instructions, and risk assessments. Support regulatory submissions, audits, and inspections. Provide technical leadership to suppliers and contract manufacturers. Support new product introduction (NPI), design transfer, and sustaining engineering activities. Collaborate cross-functionally with R&D, Quality, Supply Chain, and Operations. Mentor manufacturing and validation engineers. Ensure compliance with applicable regulations, policies, and procedures. Foster a collaborative, solution-oriented team environment. Education or Certification Requirements Bachelor’s degree in Mechanical, Electrical, Manufacturing, Biomedical Engineering, or related field. Professional Work Experience Minimum of 10 years of manufacturing engineering experience in a regulated environment. Medical device experience preferred (ISO 13485, ISO 14971). Qualifications and Skills Expertise in electromechanical manufacturing processes (PCB assembly, cable/harnessing, machining, sheet metal). Strong statistical analysis and validation experience. Knowledge of regulatory requirements for medical devices. Experience with SolidWorks and Minitab preferred. Familiarity with schematic tools (e.g., OrCAD) is a plus. Experience with single‑use device processes is desirable. Strong technical writing and documentation skills. Ability to manage projects and work cross‑functionally. Other Essentials and Key Success Factors Strong technical leadership and problem‑solving skills. High attention to detail. Collaborative and proactive mindset. Commitment to continuous improvement. Compensation This position offers a competitive salary in the range of $115,000 – $165,000 annually, along with a comprehensive benefits package. Actual compensation will be based on relevant experience, education, and market factors. In accordance with Massachusetts law, General Laws Chapter 149, Section 19B. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. As set forth in Fractyl Health, Inc’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. #J-18808-Ljbffr