New Product Development (NPD) Engineer

Creative Solutions Services, LLC; Irvine (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced NPD Engineer to support the development of electro‑mechanical medical device products, leading design from concept through development and toward manufacturing.

You will design with SolidWorks/CAD, apply GD&T, integrate mechanical and electrical components, and collaborate with engineering, quality, manufacturing and project management to meet GMP and ISO 13485, MDR and other medical device standards using DOE where applicable.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Mechatronics, or Electromechanical Engineering.
• 5–8 years of engineering experience, preferably in NPD and the medical device industry.
• Strong experience with electro‑mechanical design and product development.
• Hands‑on SolidWorks/CAD experience and GD&T knowledge.
• Experience with PLC programming, sensors, stepper motors, and motor drivers.
• Familiarity with GMP, ISO 13485, MDD, MDR and related medical device standards.
• Strong project planning, communication, and collaboration skills.

Responsibilities

• Design and develop electro‑mechanical systems, assemblies, and components for new products.
• Perform system integration of mechanical and electrical components.
• Apply stepper motors, motor drivers, sensors, and PLCs in product designs.
• Support design activities with limited supervision and contribute to NPD projects.
• Collaborate with cross-functional teams including engineering, quality, manufacturing, and project management.
• Create and modify designs using SolidWorks/CAD and apply GD&T.
• Ensure compliance with GMP and medical device standards (ISO 13485, MDR, MDD).
• Document engineering work and maintain project records.

Skills

NPD

electro‑mechanical design

GD&T

PLC programming

Automation/Robotics

Project planning

Communication

Education

Bachelor's degree in Mechanical, Biomedical, Mechatronics, or Electromechanical Engineering

Tools

SolidWorks

CAD

Job description

Job Description:

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.