Staff Mechanical Engineer

Koninklijke Philips N.V•San Diego, CA

13d•Onsite

About The Position

We are looking for a Staff Mechanical Development Engineer who will be responsible for the mechanical design and development of wearable medical monitoring devices, accessories, and associated equipment. Your role: Create 3D CAD models and detailed 2D drawings of parts and assemblies of wearable electronic medical devices. Design for functionality, reliability, usability, manufacturability, and aesthetics to ensure product excellence. Develop parts and assemblies for high volume processes such as plastic injection molding and die cutting while maintaining high quality and consistency standards. Drive the mechanical engineering development activities across Innovation, NPI and Sustaining projects for a wearable medical device Design high-volume die cut and converted parts and assemblies suitable for manufacturing and production environments. Conduct root cause analysis of issues to improve designs and successfully take products from concept to production ensuring regulatorypliance. You're the Right Fit If: You hold a bachelor's degree in mechanical engineering (advanced degree preferred) with a minimum of 10 years of experience in an FDA-regulated environment, demonstrating a strong track record of success in deliveringpliant products. You are proficient with 3D CAD modeling systems and workflow, especially SolidWorks or Onshape, and have a solid foundation in mathematics and physical modeling, enabling precise and efficient design processes. You possess deep knowledge of the material properties of metals, plastic resins, and adhesives, and understand theirpatibility with chemicals used for reprocessing, ensuring durability and performance in medical contexts. You are experienced in ing medical device safety standards and using FEA and other analysis tools to make informed design decisions that enhance product reliability, safety, and efficacy. You excel in collaborating with other engineering disciplines and industrial designers, backed by excellentmunication and interpersonal skills, as well as robust project management expertise to lead projects effectively. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this position.

Requirements

You hold a bachelor's degree in mechanical engineering (advanced degree preferred) with a minimum of 10 years of experience in an FDA-regulated environment, demonstrating a strong track record of success in deliveringpliant products.
You are proficient with 3D CAD modeling systems and workflow, especially SolidWorks or Onshape, and have a solid foundation in mathematics and physical modeling, enabling precise and efficient design processes.
You possess deep knowledge of the material properties of metals, plastic resins, and adhesives, and understand theirpatibility with chemicals used for reprocessing, ensuring durability and performance in medical contexts.
You are experienced in ing medical device safety standards and using FEA and other analysis tools to make informed design decisions that enhance product reliability, safety, and efficacy.
You excel in collaborating with other engineering disciplines and industrial designers, backed by excellentmunication and interpersonal skills, as well as robust project management expertise to lead projects effectively.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without amodation for this position.

Responsibilities

Create 3D CAD models and detailed 2D drawings of parts and assemblies of wearable electronic medical devices.
Design for functionality, reliability, usability, manufacturability, and aesthetics to ensure product excellence.
Develop parts and assemblies for high volume processes such as plastic injection molding and die cutting while maintaining high quality and consistency standards.
Drive the mechanical engineering development activities across Innovation, NPI and Sustaining projects for a wearable medical device
Design high-volume die cut and converted parts and assemblies suitable for manufacturing and production environments.
Conduct root cause analysis of issues to improve designs and successfully take products from concept to production ensuring regulatorypliance.