Our client has recently acquired a company in the Greater Boston MA area.  We are seeking a talent who can come in and vet the acquired companies' processes as the team ramps up production.  The ideal candidate will have extensive manufacturing or process engineering experience.  Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ). **specifically related to medical device capital equipment 

Position Responsibilities 

• Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).
• Demonstrated experience supporting both internally developed and externally sourced manufacturing processes within regulated environments.
• Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation.
• Proficient in use of Minitab, or similar statistical software.
• Working knowledge of risk management and design control methodologies, including FMEA, control plans, and design transfer activities.
• Experience with complex medical device manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and/or injection molding preferred.
• Familiarity with electro-mechanical and capital equipment manufacturing processes preferred.
• Ability to troubleshoot complex manufacturing and process-related issues and implement effective corrective and preventive actions.
• Ability to read, understand, and create engineering drawings using common engineering software, including GD&T interpretation for tight-tolerance components.
• Ability to conduct complex statistical, geometric, and mathematical calculations.
• Ability to conduct responsibilities substantially free from routine supervision.
• Demonstrated commitment to patient safety, product quality, and compliance with applicable quality systems and regulatory requirements.
• Ability to adopt and defend technical positions in an open and collaborative environment.
• Demonstrated project and task management skills across multiple concurrent initiatives.
• Strong technical communication skills, including the ability to write and review protocols, reports, specifications, and technical documentation.

Requirements

• Bachelor's or higher degree in Mechanical, Industrial, or Biomedical Engineering or related field.
• Prior experience within orthopedics, medical devices, or similar regulated industries.
• Strong understanding of manufacturing processes and engineering principles.
• Experience supporting product transfer and process validation activities.
• Ability to develop and update engineering documentation, including process flows, risk assessments, and work instructions.
• Proficiency in measurement system development, data analysis, and inspection readiness.
• Excellent cross-functional collaboration and communication skills.
• Attention to detail with sound judgment and problem-solving abilities.
• Experience with equipment readiness, gage management, and fixture calibration.
• Knowledge of quality systems, regulatory standards, and continuous improvement methodologies.