Mentor Worldwide LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Engineer, R&D located in Irving, Texas or Raritan, NJ.
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 and non-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:
• Contributes and leads cross-functional multidisciplinary project teams (R&D, manufacturing, marketing, regulatory, etc.) 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.
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• Conceptualizes, conducts, and leads hands-on biomedical/mechanical research in the development of new proprietary technologies, or process improvements of existing products.
• Applies high level knowledge of scientific and engineering principles to support a broad range of research and development functions supporting the development of new products and processes.
• Interacts on a daily basis with internal stakeholders as well as potentially external stakeholders (surgeons) to determine and identify unmet needs and work towards the development of products with technical, business, and regulatory viability to the business that meet those unmet needs.
• Responsible for project and program management leadership ensuring project timelines, completion of activities are on time, within budget, and within compliance, while effectively communicating project updates, risks, and issues to management on a timely basis.
• Serves as a mentor to junior level engineers and may have direct reporting duties requested and provides technical expertise to the wider group. Ensures 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
• May coordinate with outside vendors or regulatory officials
• Demonstrate independent 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
• Interact directly with customers (surgeons), commercial, and strategic marketing organizations to identify unmet needs and strategize solutions to meeting those needs. .
• Interact with supply chain and manufacturing to advance project design and process verification and validation studies
• Conduct stage gate and design review meetings for projects in your charge.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Other duties and responsibilities as needed/assigned by the manager.
Qualifications
Qualifications:
Required:
• Minimum of a Bachelor's degree in mechanical, polymer, or biomedical engineering or related field
- Minimum 4 years' experience leading projects involving cross-functional project teams, preferably in a highly regulated and design control environment, preferably involving medical devices
- Minimum 9 years of proven company work experience, in the research, development, and commercialization of medical devices or similar regulated fields(e.g. pharmaceutical)
- Possesses a proven understanding of Design Control (e.g., CFR 820.30) and a solid understanding of statistics is required.
• Working knowledge of basic statistics is required.
• Proficiency with MS Office is required
• Ability to move materials and light equipment (up to 10 pounds) as needed
Preferred:
• Master's degree in mechanical, polymer, or biomedical engineering or related field
- Previous experience in launching commercial highly regulated (Class III) medical implants or devices in a design control environment
- PMP certification or equivalent professional project leader / program manager certification
- Past experience working with material (preferably biomaterials) or manufacturing processes (preferably polymer manufacturing) is desirable.
• Previous experience with mechanical testing and/or laboratory test method development, or 3D CAD modeling including SW is beneficial
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