New Product Development (NPD) Engineer

We are looking for an experienced NPD Engineer to support the development and design of electro-mechanical systems and components for medical device products. The ideal candidate will have strong experience in New Product Development, electro-mechanical design, automation, CAD, and medical device regulatory requirements.
Responsibilities:

• Design and develop electro-mechanical systems, assemblies, and components for new products.
• Perform system integration of mechanical and electrical components.
• Identify and apply stepper motors, motor drivers, sensors, and PLC programming in product designs.
• Support mechanical, electromechanical, and developmental design activities with limited supervision.
• Contribute to New Product Development (NPD) projects from concept through development.
• Work with industrial automation, robotics, and precision instruments.
• Create and modify designs using SolidWorks/CAD and apply GD&T principles.
• Support design activities in compliance with Good Manufacturing Practices (GMP) and applicable medical device standards.
• Apply knowledge of ISO 13485, Medical Device Regulatory Standards, MDD, and MDR.
• Utilize statistical analysis and Design of Experiments (DOE) techniques where applicable.
• Prepare and maintain engineering documentation and project-related records.
• Collaborate with cross-functional teams including engineering, quality, manufacturing, and project management.

Requirements:

• Bachelor's degree in engineering, Mechanical, Biomedical, Mechatronics, or Electromechanical Engineering.
• 5 8 years of technical/engineering experience, preferably in NPD and the medical device industry.
• Strong experience in product development / New Product Development (NPD).
• Hands-on experience with electro-mechanical system and component design.
• Experience with SolidWorks/CAD and GD&T.
• Knowledge of PLC programming, stepper motors, motor drivers, and sensors.
• Experience with industrial automation, robotics, or precision instruments is a plus.
• Knowledge of GMP and medical device regulatory requirements.
• Working knowledge of ISO 13485, MDD, MDR, and related medical device standards.
• Knowledge of DOE and statistical analysis is preferred.
• Strong project planning, organizational, communication, and interpersonal skills.
• Proficiency with Microsoft Office, Word, Excel, PowerPoint, email, and web-based tools.

Preferred Qualifications:

• Experience developing regulated medical device products.
• Experience working with automated or robotic electro-mechanical systems.
• Experience supporting products from concept/design through manufacturing and commercialization.
• Strong understanding of engineering documentation and design processes.