Principal Manufacturing Engineer

Seeking a highly driven Principal Manufacturing Engineer to lead manufacturing strategy, process development, and validation for complex electromechanical products in a regulated environment. This role is a hands‑on technical leadership position responsible for new product introduction (NPI), design transfer, and sustaining manufacturing operations, ensuring scalable, compliant, and high‑quality production processes.

The ideal candidate combines deep expertise in manufacturing engineering and validation with strong cross‑functional leadership, enabling successful product commercialization and continuous process improvement.

Manufacturing Strategy & Execution

• Lead development and execution of manufacturing, test, and validation strategies aligned with regulatory requirements, product risk, and business objectives.
• Serve as the technical authority for manufacturing process development and scale‑up of electromechanical products.
• Support new product introduction (NPI), design transfer, and sustaining engineering activities.

Process Development & Validation

• Define, develop, and validate robust manufacturing processes for electromechanical assemblies.
• Develop and maintain Master Validation Plans covering equipment, processes, software, and test methods.
• Lead test method validation activities including strategy development, Gage R&R, and statistical justification of acceptance criteria.
• Ensure all validation activities comply with applicable regulatory and quality standards.
• Apply statistical tools (DOE, Cp/Cpk, MSA) to process characterization, validation, and troubleshooting.
• Analyze process data to establish control strategies and drive continuous improvement.
• Identify and implement process optimization opportunities to improve quality, yield, and efficiency.

Technical Documentation & Compliance

• Author and review validation plans, protocols, reports, work instructions, and risk assessments.
• Support regulatory submissions, audits, and inspections.
• Ensure adherence to all applicable quality systems, regulatory requirements, and internal procedures.

Cross‑Functional Leadership & Supplier Collaboration

• Collaborate with R&D, Quality, Supply Chain, and Operations to ensure seamless product commercialization.
• Provide technical guidance to suppliers and contract manufacturers.
• Mentor and support junior manufacturing and validation engineers.

Required

• Bachelor's degree in Mechanical, Electrical, Manufacturing, Biomedical Engineering, or related discipline.
• 10+ years of manufacturing engineering experience in a regulated environment.
• Strong expertise in electromechanical manufacturing processes (e.g., PCB assembly, cable/harnessing, machining, sheet metal).
• Deep experience with process validation, statistical analysis, and manufacturing documentation.
• Strong understanding of regulatory and quality standards.