Staff Engineer, R&D
Johnson & Johnson
- Raritan, NJ
- Permanent
- Full-time
- Leads multi-functional project teams in the design, development and manufacturing of breast implants, tissue expanders, and processes to fulfill clinical needs within regulatory requirements in both office and lab environments.
- Conceptualizes, conducts, and leads biomedical research to develop proprietary technologies, and process improvements.
- Applies knowledge of scientific and engineering principles to support a range of research and development functions including the creation of new products and processes.
- Engages with both internal and external partners to identify unmet needs and work towards the development of products with technical, business, and regulatory viability to address those unmet needs.
- Responsible for project and program management leadership ensuring project timelines, accurate completion of activities and stage gate reviews are timely, and within budget and compliance, while optimally presenting project updates, risks, and issues to management on a timely basis.
- Mentors team members and provides expertise to the wider group and may be asked to assume responsibility for the management of direct reports
- Provides support for audits and coordinates with vendors or regulatory officials as the need arises
- Demonstrates understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance for self and direct reports.
- Other duties and responsibilities as needed/assigned by the manager.
- Minimum of a Bachelors degree in mechanical, polymer, or biomedical engineering or related field
- Minimum 3 years' experience leading projects involving cross-functional project teams, preferably in a highly regulated and design control environment, preferably involving medical devices
- Possesses a proven understanding of Design Control (e.g., CFR 820.30) and a solid understanding of statistics is required.
- Minimum 7 years of proven company work experience, in the research, development, and commercialization of medical devices or similar regulated fields(e.g. pharmaceutical)
- Previous experience in leading cross-functional projects
- Proficiency with MS Office is required
- Ability to move materials and light equipment (up to 10 pounds) as needed
- Master's degree in mechanical, polymer, or biomedical engineering or related field
- Previous experience in leading cross-functional teams in the launch of highly regulated (Class III) medical implants or devices
- PMP certification or equivalent project leader / program manager certification
- Past experience working with materials (preferably biomaterials) or manufacturing processes (preferably polymer manufacturing) is desirable.
- Familiarity with cGMP
- Previous experience with mechanical testing and/or laboratory test method development, OR 3D CAD modeling including SW is helpful