Manufacturing Engineer II

The Manufacturing Engineer II, NPI serves as a technical liaison between Process Development, Quality, and Production, ensuring new products and processes are transferred efficiently, validated appropriately, and established with a strong foundation for long-term manufacturing success. This is a hands-on role, requiring active participation on the manufacturing floor to implement improvements, support validations, and train production personnel.

Key Areas of Focus

• Introduction and establishment of Nitinol-based manufacturing technologies such as laser cutting, shape setting, electropolishing, cleaning, and dimensional inspection using CMM and OGP equipment
• Supporting New Product Introductions (NPI) through production readiness, validation execution, and early production ramp-up
• Applying statistical and data-driven methods to characterize processes, establish capability, and support robust process transfer
• Leading assigned NPI and process improvement activities through effective communication, cross-functional coordination, milestone tracking, and regular status reporting

Responsibilities

• Support the transfer of new products and processes from Process Development into Production, ensuring manufacturing readiness, quality awareness, and product integrity during NPI and early production phases.
• Introduce and establish manufacturing processes for Nitinol-based medical device components, including laser cutting, shape setting, electropolishing, and inspection operations.
• Execute and support process validation activities including IQs, OQs, PQs, and Test Method Validations (TMVs).
• Review, generate, and maintain process documentation including Work Instructions (WIs), routers, and supporting documentation to ensure alignment with process intent.
• Assist in establishing initial job cost baselines, cycle times, and ERP standards for new products and processes.
• Apply structured root cause analysis methodologies, including DMAIC, to investigate NPI issues, early yield losses, dimensional variation, and process instability.
• Utilize statistical tools and techniques such as Design of Experiments (DOE), process capability analysis (Cp, Cpk), ANOVA, regression analysis, and hypothesis testing to identify key drivers of variation and support data-based decisions.
• Support early production process optimization efforts including setup reduction, yield improvement, operator training, and process stability enhancements.
• Provide hands-on technical support during equipment setup, troubleshooting, and qualification activities.
• Collaborate with Quality and Production teams to support resolution of early-phase NCMRs, deviations, and process risks.
• Lead assigned NPI and process-related projects by defining scope, tracking actions and milestones, managing risks, and providing clear, data-driven status updates to stakeholders.
• Serve as a technical point of contact for internal stakeholders and, as needed, customers during NPI and continuation engineering activities.

Required Qualifications

• Minimum of 3 years of experience in an engineering role within a manufacturing environment, preferably supporting New Product Introduction or process transfer activities.
• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related technical discipline, or equivalent hands-on manufacturing experience.
• Strong technical writing skills with the ability to generate and maintain process documentation, validation protocols, and reports.
• Working knowledge of regulated manufacturing environments and quality system requirements.

Preferred Qualifications

• Experience within the medical device industry and familiarity with ISO 13485 and Quality System Regulations (QSR).
• Hands-on experience with Nitinol processing or other precision manufacturing technologies.
• Exposure to laser-based manufacturing processes or similar high-precision equipment.
• Experience applying statistical methods such as DOE, ANOVA, and process capability analysis in a manufacturing environment.
• Familiarity with Lean manufacturing principles and continuous improvement methodologies.
• Experience using data analysis or visualization tools (e.g., Excel, Power BI, Minitab).
• CAD or SolidWorks experience for basic fixture or tooling support.