Staff MedTech Hardware Engineer – Instruments & Accessories

Johnson & Johnson Innovative Medicine; California (MO); On-site; USD 134,000 - 231,000; Full time

Benefits offered by this job

Performance bonus

Benefits package

On-site work at Santa Clara

Job summary

Johnson & Johnson MedTech in Santa Clara, CA seeks a Staff Product Development Engineer, Instruments & Accessories, to translate clinical needs into robust hardware designs and drive risk management within Design Control.

Collaborate with R&D, Clinical Engineering, Quality, and Regulatory to ensure devices meet safety and performance standards, mentoring teams and guiding verification strategies.

Qualifications

• Bachelor’s degree in Biomedical or Mechanical Engineering.
• 8+ years of product development experience in medical devices or regulated industries.
• Strong experience with Design Control and cross-functional product development from concept through commercialization.
• Experience with requirements management, risk management, and design verification.
• Hands-on experience with devices integrating hardware, disposables, software, and capital equipment.

Responsibilities

• Lead hardware design development from concept to commercialization following Design Control.
• Own creation, management, and traceability of user, system, and subsystem requirements.
• Lead system-level risk management activities including hazard analyses and FMEAs.
• Develop and support design verification and validation strategies.
• Partner with R&D, Clinical Engineering, Quality, Regulatory, Manufacturing, and Product Management teams.

Skills

Design Control

Hardware design

Requirements management

Risk management

Cross-functional collaboration

Regulatory compliance

Project management

Communication skills

Mentoring teams

Education

Bachelor in Biomedical/Mechanical Engineering

Tools

Jama

Job description

Johnson & Johnson MedTech in Santa Clara, CA seeks a Staff Product Development Engineer, Instruments & Accessories, to translate clinical needs into robust hardware designs and drive risk management within Design Control.

Collaborate with R&D, Clinical Engineering, Quality, and Regulatory to ensure devices meet safety and performance standards, mentoring teams and guiding verification strategies.