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. 

• →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.

• Bachelor’s degree in Mechanical, Electrical, Manufacturing, Biomedical Engineering, or related field.

• Minimum of 10 years of manufacturing engineering experience in a regulated environment.
• Medical device experience preferred (ISO 13485, ISO 14971).

• 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.

• Strong technical leadership and problem-solving skills.
• Excellent written and verbal communication.
• High attention to detail.
• Collaborative and proactive mindset.
• Commitment to continuous improvement.