We are seeking an experienced NPI Process Engineer to support new product introduction and product development activities, with a focus on electro-mechanical systems, equipment design, process development, and manufacturing automation. The ideal candidate will have experience in CAD design, PLC programming, process improvement, and validation, preferably within the medical device industry.
Required Qualifications
- Experience supporting New Product Introduction (NPI) and New Product Development (NPD) activities.
- Proficiency in SolidWorks and other CAD tools, including Geometric Dimensioning and Tolerancing (GD&T).
- Experience designing and developing mechanical and electro-mechanical systems and components.
- Knowledge of PLC programming, stepper motors, motor drivers, sensors, and industrial automation.
- Experience integrating mechanical and electrical components into functional systems.
- Knowledge of manufacturing process development, equipment design, and process optimization.
- Familiarity with medical device manufacturing practices and regulatory standards, including ISO 13485, MDD, and MDR.
- Experience with process and product validation, statistical analysis, and Design of Experiments (DOE) is preferred.
- Strong technical documentation, communication, organizational, and project management skills.
- Proficiency in Microsoft Office applications and project planning tools, including Microsoft Project.
Roles and Responsibilities
- Design, develop, and implement manufacturing equipment and processes to support new product development and introduction.
- Develop mechanical and electro-mechanical systems, components, and equipment based on product and manufacturing requirements.
- Integrate mechanical and electrical components, including motors, sensors, drivers, and PLC-based control systems.
- Evaluate existing manufacturing processes and implement improvements to enhance productivity, quality, reliability, and efficiency.
- Identify opportunities for automation and implement appropriate solutions to improve manufacturing operations.
- Prepare, review, and maintain equipment specifications, design documentation, technical procedures, and related records.
- Coordinate equipment design, procurement, installation, and implementation while ensuring compliance with applicable safety and environmental requirements.
- Perform process and product validation activities to ensure equipment and processes meet established specifications and quality standards.
- Apply statistical analysis and Design of Experiments (DOE) techniques to support process optimization and problem-solving.
- Provide technical guidance to technicians and engineers in resolving equipment, design, and manufacturing process issues.
- Ensure compliance with applicable manufacturing procedures, quality requirements, and medical device regulatory standards.
- Collaborate with engineering, manufacturing, quality, and product development teams to support successful product launches.
- Communicate project progress, technical challenges, and improvement opportunities to management.
- Perform additional duties as required to support engineering and manufacturing objectives.