New Product Development Engineer - Process

Job Summary

The NPD Engineer – Process is responsible for supporting the design, development, and transfer of medical devices from concept through production, with a focus on manufacturing processes, tooling, and design for manufacturability.

Job Responsibilities

• Supports design, development, and validation activities throughout the product lifecycle in alignment with project scope and objectives.
• Applies design control processes to ensure products are manufacturable, cost-effective, and compliant with applicable standards.
• Translates customer requirements into engineering specifications and process requirements.
• Supports design for manufacturability (DFM) and design for assembly (DFA) activities early in development.
• Develops and implements manufacturing processes, tooling, and fixturing to support production.
• Creates and maintains manufacturing procedures, test methods, and inspection plans to ensure quality and reduce risk.
• Supports engineering change implementation, including documentation updates and training of production personnel.
• Designs and executes experiments (DOE), testing, and characterization to evaluate and improve process performance.
• Applies statistical tools and engineering analysis to improve process capability and product performance.
• Evaluates new technologies and implements improvements to enhance efficiency and quality.
• Collaborates with engineering, operations, quality, and customers to support successful product transfer to production.
• Provides guidance and support to technicians and operators in prototyping, testing, and process development activities.
• Contributes to project deliverables and timelines through effective communication and coordination.
• Provides input into quotes to ensure accuracy and quick turnaround.

Qualifications

• Bachelor’s Degree in Engineering with 2 years of medical device experience.
• Strong understanding of design controls, process development, and characterization of test methods for selection, verification, and validation of components, sub-systems, and assemblies.
• Proficiency in 3D modeling (SolidWorks preferred) and working knowledge of drafting specifications.
• Complex problem-solving skills, including the use of statistical techniques such as DOE, ANOVA, t-tests, normality, and process capability metrics in decision-making.
• Strong technical writing skills.
• Excellent internal and external communication, presentation, follow-through, and organizational skills.
• Proven ability to work effectively with coworkers at all levels of the organization.
• Proven ability to lead other engineers and/or techs in supporting aspects of process development.
• Six Sigma Green/Black Belt Certification (preferred)