Staff Engineer, MedTech Surgery R&D (Hybrid)

Johnson & Johnson MedTech; Raritan (NJ); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation – 120 hours/year

Sick time – 40 hours/year

Holiday pay – 13 days/year

Parental Leave – 480 hours/year

Bereavement Leave – 240 hours

Job summary

Johnson & Johnson MedTech is seeking a Staff Engineer, R&D based in Irving, TX, with a hybrid schedule. You will lead design and development of breast implants and tissue expanders, guiding projects from concept through transfer to commercialization while ensuring regulatory and GMP standards are met.

Ideal candidates have a strong background in mechanical/biomedical engineering, 8+ years in medical devices, and experience with design controls and PLM systems.

Qualifications

• Minimum 8 years of proven work experience in the research, development, and commercialization of medical devices or similar regulated fields.
• Proficient in Design Control (e.g., CFR 820.30) and statistics.
• Experience with regulated product development and design transfer processes.

Responsibilities

• Leads project and/or technical teams in design, development and manufacturing of breast implants, tissue expanders, and related processes.
• Applies engineering principles to support a broad range of R&D functions and milestones.
• Manages project timelines, budgets, risks, and communicates updates to management.
• Interacts with surgeons, marketing, and regulatory to identify unmet needs and ensure viability of new products.
• Collaborates with supply chain, manufacturing, and suppliers to advance development through transfer to commercialization.
• Supports regulatory submissions and audit activities as a technical SME.
• Demonstrates GMP fundamentals including data integrity and GDPs.
• Ensures compliance with all health, safety, and environmental regulations.

Skills

Design Control

Cross-functional collaboration

Project management

MS Office

Windchill

PLM systems

Education

Bachelor’s degree in mechanical or biomedical engineering

Master’s degree (preferred)

Tools

Windchill PLM

MS Office

Job description

Johnson & Johnson MedTech is seeking a Staff Engineer, R&D based in Irving, TX, with a hybrid schedule. You will lead design and development of breast implants and tissue expanders, guiding projects from concept through transfer to commercialization while ensuring regulatory and GMP standards are met.

Ideal candidates have a strong background in mechanical/biomedical engineering, 8+ years in medical devices, and experience with design controls and PLM systems.