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Staff Engineer, R&D - 2406179374W

Description

Mentor Worldwide LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Staff 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 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.

Qualifications

Qualifications:

Education:

• Minimum of a Bachelors degree in mechanical, polymer, or biomedical engineering or related field

Required:

• 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

Preferred:

• 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

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.

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.

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 .

Primary Location NA-US-New Jersey-Raritan

Other Locations NA-US-Texas-Irving

Organization Mentor Worldwide LLC (6177)

Relocation Eligible: No

Travel Yes, 10 % of the Time

Job Function Biomedical Engineering

Req ID: 2406179374W