About the role
Responsibilities
Lead complex manufacturing process design and improvement activities to ensure the safety and efficacy of components and finished medical devices
Independently lead qualification, verification, and validation (QVV) of manufacturing processes, equipment, and product lines for medical device production
Troubleshoot and resolve issues related to product safety, quality, cost, delivery, and process performance
Drive engineering initiatives and new product development, including technology development, process studies, Six Sigma projects, materials testing, and intellectual property generation
Design and develop manufacturing equipment in compliance with safety regulations such as OSHA and EPA standards
Participate in design control efforts, including risk analysis (FMEA), design reviews, and validation protocols
Lead supplier sourcing and evaluation efforts to assess capability, quality, and effectiveness of external partners and service providers
Direct controlled environment operations, including cleanroom design, equipment maintenance, and troubleshooting
Mentor and train cross-functional teams, including engineers, technicians, and operators, while also supporting post-market surveillance and product performance reviews
Lead and coordinate cross-functional project teams, manage timelines, define goals, evaluate engineering tests and experiments, and identify opportunities for process optimization and cost savings
Requirements
Bachelor's degree in engineering or related technical field - required
4+ years of relevant experience - required
Ability to conduct complex statistical, geometric, and mathematical calculations
Ability to read, understand, create engineering drawings on common engineering software
Ability to mentor Engineers and other technical staff
Proficient in use of Minitab, or similar, statistical software - preferred