Senior Engineer, R&D - Johnson and Johnson
Irving, TX 75014
About the Job
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
The Senior Engineer, R&D will have the responsibility of leading and contributing to various cross-functional multidisciplinary project teams, such as R&D, manufacturing, marketing, and regulatory and will work on designing, developing and manufacturing of Mentor products - Breast Implants, Tissue Expanders, and other related products.
Responsibilities/Duties
- Lead conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements
- Contribute to design/development of product line extensions and product improvements
- Help lead design, development, execution and analysis of results of system, device, component and material tests per laboratory best practices
- Accurately and efficiently translate user and patient needs through design requirements, design specifications and into verified/validated devices and procedures
- Lead verification and validation activities through regulatory clearance and design transfer
- Contribute strongly in the generation of intellectual property
- Collaborate with external (e.g., clinicians) and internal customers (e.g., strategic marketing) to identify user needs and validate device and procedure designs
- Collaborate with clinical, regulatory, quality, manufacturing, etc., to ensure development of innovative and reliable devices that fulfill clinical needs within regulatory requirements
- Help manage development partners and other external vendors to meet project requirements and timelines
- Coordinate and execute technical and peer reviews; may also include coordination and execution of design reviews
- May involve direct or indirect supervision of engineers and/or technicians
- Other responsibilities as required or assigned by manager
Required:
- A minimum of a Bachelor's degree in mechanical or biomedical engineering or related field, preferably mechanical engineering
- At least 4 years medical device industry experience
- Familiar with design control requirements
- Good written and verbal communication skills
- 5-10 years of experience in design, development, and commercialization of Class I-III medical devices, specifically electro-mechanical, disposable, minimally invasive, handheld surgical devices
- Project Management Experience
- Experience in working with cross-functional teams.
- Familiar with GMP & GLP
- Designing with 3D CAD tools, including SolidWorks and rapid prototyping, including hands-on manual prototyping, SLA and FDM
- Experience in test method validation
- Experience in executing design verification and validation
- Location - Irving TX / Raritan NJ
- Travel - Less than 10% travel required
- Office and lab environment
- Ability to move materials and light equipment (up to 10 pounds) as needed
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 .
This job posting is anticipated to close on July 15, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
The anticipated base pay range for this position is $88,000- $141,450