Staff Manufacturing Engineer

Responsibilities

• Provide daily engineering support for Nitinol melting, casting, and downstream material processing operations
• Troubleshoot process, material, and equipment issues to minimize downtime and scrap
• Develop, update, and maintain manufacturing documentation including work instructions and process specifications
• Monitor and analyze process performance and implement improvements
• Lead and support continuous improvement initiatives using Lean and Six Sigma methodologies
• Improve process capability (Cp/Cpk), yield, and throughput
• Identify and implement cost reduction opportunities through process optimization and material utilization
• Support transfer and scale-up of new Nitinol materials and processes into production
• Assist with process development, manufacturability assessments, and production readiness
• Execute process validation activities (IQ/OQ/PQ) and ensure compliance with internal requirements
• Ensure adherence to FDA, ISO 13485, and internal quality system requirements
• Support nonconformance investigations, root cause analysis, and corrective/preventive actions (CAPA)
• Partner with Quality to define process controls and inspection requirements
• Collaborate with Operations, Quality, R&D, and Supply Chain
• Provide technical guidance to operators, technicians, and junior engineers
• Contribute to a culture of safety, accountability, and continuous improvement

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field
• 5+ years of manufacturing engineering experience
• Experience in a regulated manufacturing environment (medical device, aerospace, or similar) preferred
• Experience with metals processing; Nitinol or specialty alloys strongly preferred
• Technical Skills: Knowledge of manufacturing processes such as melting, heat treatment, forming, machining, or finishing
• Experience with statistical analysis and data-driven problem solving (e.g., Minitab)
• Familiarity with process validation (IQ/OQ/PQ)
• Ability to interpret engineering drawings and GD&T
• Core Competencies: Strong analytical and problem-solving skills
• Effective communication and cross-functional collaboration
• High attention to detail with a focus on quality and compliance
• Continuous improvement mindset

Additional Information

• Work Environment: Manufacturing floor and office environment supporting Nitinol materials production
• Travel: Up to 10% as needed
• FLSA Status: Exempt