Associate Director Biosurgery R&D LCM
Biopharma Careers
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Benefits offered by this job
Job summary
Johnson & Johnson is seeking an Associate Director Biosurgery, R&D Lifecycle Management to lead R&D activities for the Biosurgery product portfolio. You’ll manage a team of professionals and oversee Design Controls, verification, and validation activities to ensure quality and regulatory readiness.
The role requires 8+ years in leadership, strong collaboration across functions, and travel up to 20%. This is a high-impact opportunity within MedTech development and lifecycle management.
Qualifications
- BS in Engineering/Science is required; MS/PhD preferred.
- Significant experience in R&D, lifecycle management, or related leadership within MedTech or healthcare is required.
- 8+ years of people leadership experience with cross-functional teams.
- Knowledge of Design Controls is required.
- Experience in Medical Device industry or medical field is required.
- Process validation principles and practices knowledge.
- Excellent collaboration and influencing skills across R&D, Supply Chain, Quality, Regulatory.
Responsibilities
- Provide scientific direction and leadership of R&D activities in support of Lifecycle Management projects.
- Oversee LCM projects and identify opportunities for improvements to achieve business goals.
- Ensure project timelines and milestones are met.
- Review documentation including Design Controls, verification/validation protocols and reports.
- Ensure compliance with safety, efficacy and clinical practice requirements.
- Hire, mentor, and develop staff for growth.
- Present programs at senior management meetings and ensure data quality.
- Communicate business issues to management and ensure compliance with guidelines.
Skills
Education
Tools
Job description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
R&D Product Development
Biomedical Engineering
People Leader
Raritan, New Jersey, United States of America
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
The Associate Director Biosurgery, R&D Lifecycle Management (LCM) - MedTech is responsible for leading and directing Research and Development activities within the Biosurgery portfolio of products to best serve the needs of the customers and business while having responsibility for managing a group of professionals.
- Provide for scientific direction and leadership of research and development activities in support of Lifecycle Management (LCM) projects including Design Changes, Process Changes and base business support.
- Oversight of LCM projects and identify opportunities for improvements to achieve business goals.
- Ensure project timelines and all required project milestones are met.
- Review of documentation including Design Control documents (including Design Verification and Design Validation Protocols and Reports), claims support, regulatory submissions and technical reports for internal use and regulatory submission.
- Review and evaluate research and development protocols to ensure activities comply with industry, company and regulatory expectations for safety, efficacy and compatibility with standard clinical practice.
- Hire, motivate, develop and mentor staff to provide employee growth.
- Presents on programs at senior management meetings and ensures the scientific integrity and quality of all data produced.
- Responsible for communicating business-related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
- BS in Engineering/Science is required preferably in Chemical Engineering, Mechanical Engineering, Materials Science, Polymer Science or Biomedical Engineering; Advanced Degree (MS, PhD) is preferred.
- Significant experience in R&D, lifecycle management, or related leadership roles within MedTech, medical devices, or healthcare is required.
- Proven people and change leadership skills, including 8+ years of people leadership experience, with the ability to lead cross-functional teams and drive transformation in a dynamic, matrixed environments are required.
- Knowledge of Design Controls is required.
- Experience in the Medical Device industry or medical field is required.
- Demonstrated knowledge of process validation principles and practices, and procedures is required.
- Excellent collaboration and influencing skills, enabling effective partnership across R&D including Supply Chain, Quality, Regulatory, and commercial functions is required.
- Experience in Biosurgery product categories (hemostats, sealants, adhesives, tissue scaffolds) is preferred.
- This position requires approximately 20% domestic and/or international travel.
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 federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
- Bioinformatics
- Biological Engineering
- Biostatistics
- Controls Compliance
- Developing Others
- Financial Competence
- Global Market
- Healthcare Trends
- Inclusive Leadership
- Leadership
- Medical Affairs
- Process Improvements
- Product Development
- Research and Development
- Researching
- Resource Planning
- SAP Product Lifecycle Management
- Team Management
- Leadership
- Medical Affairs
- Process Improvements
- Product Development
- Research and Development
- Researching
- Resource Planning
- SAP Product Lifecycle Management
- Team Management
$137,000.00 - $235,750.00
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation -120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
- 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 period10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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