Mentor Worldwide LLC,. a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Engineer R&D located in Raritan, NJ or Irving, TX..
This position supports the Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson. The CSS Group consists of four diverse businesses including Acclarent, Biosense Webster (BWI), Cerenovus, and Mentor.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics. Learn more about Mentor at www.mentorwwllc.com
Key Responsibilities :
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 Master’s (MS) degree in mechanical, polymer, or biomedical engineering or related field, or equivalent
- Minimum 1 year experience leading projects involving project teams, preferably in a highly regulated or design control environment, preferably involving medical devices
- Minimum 8 years of proven experience, preferably in the research, development, and commercialization of medical devices or equivalent regulated device
- Possesses a proven understanding of Design Control (e.g., CFR 820.30) and a solid understanding of statistics
- Proficiency with MS Office
- Previous experience with mechanical testing and/or laboratory test method development, or 3D CAD modeling including SW
- Previous experience in launching commercial 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
- Location: Somerville, NJ or Irving, TX
- Travel: Less than 10% travel required
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For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.