R/D Engineer – Senior/Principal Level

Express Employment Professionals - Cincinnati East; San Clemente (CA); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Medical benefits

Training opportunities

Scholarship opportunities

Job summary

Express Employment Professionals, Laguna Hills, seeks an experienced R&D Engineer (Senior/Principal) to design and develop medical device products, processes, tooling, and fixtures. You will lead prototype builds and coordinate with Manufacturing, Quality, Engineering, and vendors to keep R&D projects on schedule.

The ideal candidate has 5+ years in the medical device field, a Bachelor's in Engineering, and hands-on experience with GMP and testing.

Qualifications

• Bachelor's degree in Engineering (required).
• 5+ years of experience in the medical device industry.
• Experience developing and launching medical devices.
• SolidWorks experience is required or strongly preferred.

Responsibilities

• Design and develop new medical device products, processes, tooling, and fixtures.
• Lead prototype and pilot production builds.
• Coordinate with Manufacturing, Quality, Engineering, and vendors.
• Plan and manage R&D projects and timelines.
• Support product testing, GMP, and quality system requirements.

Skills

SolidWorks

Project management

Communication skills

Problem solving

Attention to detail

Education

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ knowledge

Catheter-based testing

Job description

R&D Engineer – Senior/Principal Level

Express Employment Professionals, Laguna Hills is recruiting for an R&D Engineer.

Service Line: Direct Hire, Full-time

Pay: $100,000 – $140,000/year DOE

Responsibilities:

• Design and develop new medical device products, processes, tooling, and fixtures
• Improve existing products and manufacturing processes
• Lead prototype and pilot production builds
• Develop and test product concepts and materials
• Create technical documentation, drawings, and qualification protocols
• Coordinate with Manufacturing, Quality, Engineering, and outside vendors
• Plan and manage R&D projects and timelines
• Support product testing, clinical cases, and animal trials as needed
• Assist with new product launches and product improvements
• Support GMP, FDA, and quality system requirements
• Contribute to product development and intellectual property initiatives

Requirements:

• 5+ years of experience in the medical device industry
• Bachelor's degree in Engineering
• Experience developing and launching medical devices
• Vascular device experience strongly preferred
• Strong knowledge of medical device quality systems and GMP
• Experience with catheter-based device testing
• Prototype design and hands-on building experience
• Experience with medical device manufacturing processes and IQ/OQ/PQ
• Experience with product testing and inspection equipment
• Machine shop experience preferred
• Advanced/intermediate SolidWorks skills
• Strong communication, organization, and problem-solving skills
• Ability to manage multiple projects and work with minimal supervision
• Strong attention to detail and ability to meet deadlines

Benefits of working with Express include medical benefits, training, and scholarship opportunities.