R&D Engineer II / Senior R&D Engineer - Medical Devices

gpac; Irvine (CA); On-site; USD 80,000 - 130,000; Full time

Benefits offered by this job

Full benefits

Relocation assistance

Day shift

Job summary

gpac is seeking an R&D Engineer II / Senior R&D Engineer for a medical device manufacturer in Mecklenburg County, NC. You will design and develop Class II/III devices, including catheters, from concept through production, leading cross-functional teams as needed.

Qualifications include a BS or MS in Biomedical or Mechanical Engineering and 3+ years (6+ for senior) in medical device engineering. Relocation assistance and full benefits are offered.

Qualifications

• BS or MS in Biomedical Engineering or Mechanical Engineering.
• Engineer II: 3+ years of medical device engineering experience; Senior: 6+ years.
• Catheter experience is a plus.
• Experience with validation (IQ/OQ/PQ) and design controls.

Responsibilities

• Design and develop catheters and devices from concept to production with prototyping.
• Design components, tooling and fixtures in SolidWorks or CAD.
• Develop pilot and production tooling, fixtures and assembly processes and support equipment qualification and validation.
• Plan, execute and report verification and validation and prepare design history files.
• Support manufacturing with troubleshooting and process improvements and design changes.
• Communicate project status, risks and feasibility with cross-functional teams.
• Work with outside vendors on materials, components, tooling and processes.
• Senior level: lead technical execution, mentor junior engineers and contribute to quoting and project planning.

Skills

Strong problem-solving

Cross-functional collaboration

Effective communication

Education

BS or MS in Biomedical or Mechanical Engineering

Tools

SolidWorks

Job description

An established medical device manufacturer in Mecklenburg County, NC is hiring an R&D Engineer II / Senior R&D Engineer to design and develop Class II and Class III medical devices across cardiology, neurology and urology. You'll support or lead cross-functional teams from concept through commercialization. Candidates from anywhere in the U.S. who are willing to relocate are welcome, and a $10,000 relocation package is provided.

What You'll Do

• Design and develop catheters and other medical devices from concept through production, including hands-on assembly and prototyping
• Design components, devices, tooling and fixtures in SolidWorks or equivalent CAD
• Develop pilot and production tooling, fixtures, equipment and assembly processes, and support equipment qualification and validation
• Plan, execute and report verification and validation, and prepare design control documentation (protocols, reports, drawings, design history file)
• Support manufacturing with troubleshooting, process improvements and design changes
• Communicate project status, risks and technical feasibility, and work with Quality, Manufacturing, Supply Chain and Project Management
• Work with outside vendors on materials, components, tooling and processes
• Senior level: lead technical execution, mentor junior engineers and contribute to quoting and project planning

What You Bring

• BS or MS in Biomedical Engineering, Mechanical Engineering or a related discipline
• Engineer II: 3+ years of medical device engineering experience; Senior: 6+ years
• Strong medical device design and development experience; catheter experience is a big plus
• Proficiency in SolidWorks or equivalent CAD, with hands-on prototyping and lab experience
• Knowledge of materials and manufacturing processes such as thermal bonding, PTFE processing and fixture design
• Experience with validation (IQ/OQ/PQ) and design controls
• Strong problem-solving and communication skills

What's Offered

• Engineer II: $80,000 - $110,000; Senior: $100,000 - $130,000
• Full benefits
• Open to candidates willing to relocate, with $10,000 relocation assistance
• Day shift, Monday to Friday, 7am - 4pm

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.