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.
- 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.
- 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.