Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field
2-5 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
Knowledge of manufacturing processes such as tube conversion, strip processing, annealing, wire EDM, centerless grinding preferred
Experience with statistical analysis and data-driven problem solving (e.g., Minitab)
Familiarity with process validation (IQ/OQ/PQ)
Responsibilities
Provide daily engineering support for material processing operations
Troubleshoot process, material, and equipment issues to minimize downtime and scrap
Develop, update, and maintain manufacturing documentation including work instructions, MOM/BOM configuration and process specifications
Monitor and analyze process performance and implement improvements
Lead and support continuous improvement initiatives using Lean and Six Sigma methodologies
Support transfer and scale-up of new Nitinol materials and processes into production
Ensure adherence to FDA, ISO 13485, and internal quality system requirements
Benefits
Collaborative work environment with cross-functional teams
Opportunities for professional development and continuous improvement
Hands-on experience with cutting-edge Nitinol materials
Engagement in meaningful projects within a regulated industry
Focus on quality and compliance in manufacturing processes
Full Job Description
Salary Range: $87,400.00 - $145,600.00
Job Description:
The Manufacturing Engineer, II is a junior level individual contributor responsible for supporting and optimizing manufacturing processes within the Nitinol Materials operations. This role provides hands-on engineering support, drives continuous improvement initiatives, and partners cross-functionally to ensure high-quality, efficient production of Nitinol materials. The role operates on moderately complex problems and contributes to process scalability, cost efficiency, and product quality.
Responsibilities
Manufacturing Engineering Support:
Provide daily engineering support for material processing operations
Troubleshoot process, material, and equipment issues to minimize downtime and scrap
Develop, update, and maintain manufacturing documentation including work instructions, MOM/BOM configuration and process specifications
Monitor and analyze process performance and implement improvements
Process Improvement:
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
New Product & Process Introduction:
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
Quality & Compliance:
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
Collaboration & Technical Contribution:
Partner cross-functionally 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
Education & Experience:
Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field
2-5 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
Knowledge of manufacturing processes such as tube conversion, strip processing, annealing, wire EDM, centerless grinding preferred.
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
Ability to work independently with sound technical judgment
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
