Staff R&D Engineer
Johnson & Johnson, Irvine, CA, United States
Overview
The Staff R&D Mechanical Engineer is a seasoned individual contributor responsible for delivering engineering expertise across all stages of the product lifecycle. This role applies advanced engineering principles to support
device design, development, verification, validation, and manufacturing transfer
of regulated medical devices, with a strong focus on
catheter-based technologies . The role partners closely with cross‑functional teams to deliver safe, effective, and compliant products to market.
Responsibilities
Provide advanced mechanical engineering support throughout
design, development, verification, validation, and commercialization
of medical devices.
Lead and contribute to
device design and development activities , including component and system-level design.
Support and review
Design Verification Testing (DVT)
and
Verification & Validation (V&V)
activities to ensure compliance with regulatory and product requirements.
Apply proven scientific and engineering methodologies to develop high-quality, innovative products.
Collaborate closely with Manufacturing, Quality, Regulatory, and Clinical partners to support
design for manufacturability
and smooth product transfer.
Investigate, document, and resolve reported incidents to maintain product quality and reliability.
Prepare and review technical documentation, reports, test protocols, and design history file content.
Develop proposals for new R&D initiatives in support of capital expenditure planning.
Coach and mentor junior engineers in methods, tools, and best practices.
Demonstrate and apply Johnson & Johnson’s Credo and Leadership Imperatives in daily work.
Required & Preferred Experience
Hands-on experience in catheter design and development , including component or system-level ownership.
Experience supporting products through
DVT and V&V phases
in a regulated environment.
Experience working on
Class II and/or Class III medical devices .
Strong background in
mechanical design, device development, and/or manufacturing engineering .
Experience partnering with Manufacturing or Operations teams to ensure robust, scalable designs.
Working knowledge of design controls, risk management, and regulatory requirements for medical devices.
Qualifications
Bachelor’s degree in Mechanical Engineering or a related engineering discipline (advanced degree preferred).
Proven experience in mechanical engineering within a medical device R&D environment.
Strong analytical, problem-solving, and technical documentation skills.
Ability to work independently while contributing effectively to cross-functional teams.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by law.
Johnson & Johnson is committed to providing an inclusive interview process. If you require an accommodation, please contact the Employee Health Support Center or AskGS for assistance.
Required Skills:
Preferred Skills:
Coaching, Contract Management, Critical Thinking, Design Thinking, Fact-Based Decision Making, Feasibility Studies, Incident Management, Mechanical Engineering, Organizing, Process Oriented, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technical Writing, Vendor Management
The anticipated base pay range for this position is :
$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
#J-18808-Ljbffr
The Staff R&D Mechanical Engineer is a seasoned individual contributor responsible for delivering engineering expertise across all stages of the product lifecycle. This role applies advanced engineering principles to support
device design, development, verification, validation, and manufacturing transfer
of regulated medical devices, with a strong focus on
catheter-based technologies . The role partners closely with cross‑functional teams to deliver safe, effective, and compliant products to market.
Responsibilities
Provide advanced mechanical engineering support throughout
design, development, verification, validation, and commercialization
of medical devices.
Lead and contribute to
device design and development activities , including component and system-level design.
Support and review
Design Verification Testing (DVT)
and
Verification & Validation (V&V)
activities to ensure compliance with regulatory and product requirements.
Apply proven scientific and engineering methodologies to develop high-quality, innovative products.
Collaborate closely with Manufacturing, Quality, Regulatory, and Clinical partners to support
design for manufacturability
and smooth product transfer.
Investigate, document, and resolve reported incidents to maintain product quality and reliability.
Prepare and review technical documentation, reports, test protocols, and design history file content.
Develop proposals for new R&D initiatives in support of capital expenditure planning.
Coach and mentor junior engineers in methods, tools, and best practices.
Demonstrate and apply Johnson & Johnson’s Credo and Leadership Imperatives in daily work.
Required & Preferred Experience
Hands-on experience in catheter design and development , including component or system-level ownership.
Experience supporting products through
DVT and V&V phases
in a regulated environment.
Experience working on
Class II and/or Class III medical devices .
Strong background in
mechanical design, device development, and/or manufacturing engineering .
Experience partnering with Manufacturing or Operations teams to ensure robust, scalable designs.
Working knowledge of design controls, risk management, and regulatory requirements for medical devices.
Qualifications
Bachelor’s degree in Mechanical Engineering or a related engineering discipline (advanced degree preferred).
Proven experience in mechanical engineering within a medical device R&D environment.
Strong analytical, problem-solving, and technical documentation skills.
Ability to work independently while contributing effectively to cross-functional teams.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by law.
Johnson & Johnson is committed to providing an inclusive interview process. If you require an accommodation, please contact the Employee Health Support Center or AskGS for assistance.
Required Skills:
Preferred Skills:
Coaching, Contract Management, Critical Thinking, Design Thinking, Fact-Based Decision Making, Feasibility Studies, Incident Management, Mechanical Engineering, Organizing, Process Oriented, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technical Writing, Vendor Management
The anticipated base pay range for this position is :
$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
#J-18808-Ljbffr