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Staff Engineer – MedTech Surgery, R&D
Johnson & Johnson. Lead project and/or technical teams in designing, developing, and manufacturing breast implants, tissue expanders, and related processes .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading cross-functional teams in the design, development, and commercialization of medical devices, with a strong focus on regulatory compliance and project management. Proficient in applying scientific principles and methodologies to advance product development while ensuring adherence to Good Manufacturing Practices.
Highest-signal resume keywords
Project ManagementDesign ControlRegulatory ComplianceBiomedical EngineeringCross-Functional Team Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Biomedical EngineeringDesign ControlStatistical AnalysisMechanical TestingTest Method DevelopmentTest Method ValidationManufacturing ProcessesPolymer EngineeringData IntegrityGood Manufacturing Practices
Soft Skills
CommunicationCollaborationProblem-SolvingLeadership
Tools & Technologies
MS OfficePLM SystemWindchill
Industry Keywords
Medical DevicesClass III ImplantsRegulated EnvironmentHuman FactorsUsabilityEthnographic ResearchProcess Mapping
About the role
Key responsibilities & impact- Lead project and/or technical teams in designing, developing, and manufacturing breast implants, tissue expanders, and related processes
- Apply scientific and engineering principles across research and development functions
- Advance development projects through design control and stage deliverable milestones
- Lead projects and manage timelines, activities, budgets, compliance, risks, and issues
- Communicate project updates, risks, and issues to management
- Interact with key opinion leaders, surgeons, commercial teams, and strategic marketing to identify unmet needs
- Develop products with technical, business, and regulatory viability
- Collaborate with supply chain, manufacturing, and internal or external suppliers
- Advance projects through concept generation, feasibility, verification, validation, design transfer, and commercialization
- Support regulatory submissions and audits as a technical subject-matter expert
- Apply GMP fundamentals, including Data Integrity, Good Manufacturing Practices, and Good Documentation Practices
- Ensure compliance with health, safety, environmental, federal, state, local, and company requirements
Requirements
What you’ll need- Minimum of a Bachelor’s degree in mechanical or biomedical engineering or related field
- Minimum 8 years of proven company work experience in research, development, and commercialization of medical devices or similar regulated fields
- Education or experience with polymer, chemical engineering, or material science desirable
- Proven understanding of Design Control, including CFR 820.30
- Solid understanding of statistics
- Proficient in MS Office
- File management within a PLM system; Windchill preferred
- Ability to move materials and light equipment up to 10 pounds
- Previous experience launching highly regulated Class III medical implants or devices in a design control environment preferred
- Previous experience in industrial design, human factors, ethnographic research, process mapping, or usability desirable
- Hands-on experience with manufacturing processes of absorbable polymers or scaffolds is a plus
- Previous experience with polymer-based biomaterials and related manufacturing processes desirable
- Previous experience leading cross-functional project teams or serving as technical lead in a highly regulated environment desirable
- Previous experience with mechanical testing, test method development, and test method validation desirable
Benefits
Comp & perks- Retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; for employees residing in Colorado – 48 hours; for employees residing in Washington – 56 hours
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Inclusive interview process and accommodation support