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Job Function: R&D Product Development
Job Sub Function: Biomedical Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Irving, Texas, United States of America
Job Description:About SurgeryFueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of MedTech surgery? Ready to join a team that's reimagining how we heal? Our MedTech Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at ;br>
We are searching for the best talent for a Staff Engineer position. This position is based in Irving Texas with a hybrid schedule (3 days in office, 2 days remote or as required in office)Purpose:The Aesthetics & Reconstruction business unit of Johnson & Johnson MedTech Surgery, is recruiting for a Staff Engineer, R&D located in Irving, Texas.
The Aesthetics & Reconstruction business unit operating under the Mentor brand, 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 ;br>
You will be responsible for:- Leads project and/or technical 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.
- 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, including advancing development projects toward achieving both design control and stage deliverable milestones on a timely basis.
- Potentially involves leading projects and being responsible for project and program management of 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.
- Interact with KOLs, customers (surgeons), commercial, and strategic marketing organizations to identify unmet needs and work towards the development of products with technical, business, and regulatory viability to the business that meet those unmet needs.
- Interact with cross-functional stakeholders in supply chain, manufacturing, as well as internal or external suppliers to advance development projects through concept generation, feasibility, verification, validation, and design transfer through to commercialization
- Interact with regulatory colleagues in support of regulatory submissions and participate in audit support as a technical SME
- 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 for Health, Safety and Environmental compliance
Qualifications / Requirements:Required:- Minimum of a Bachelor's degree in mechanical or biomedical engineering or related field
- Education or Experience with polymer, chemical engineering, or material science desirable
- Minimum 8 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.
- Proficient in the use of software (MS office) and file management within a PLM system (Windchill preferred)
- Ability to move materials and light equipment (up to 10 pounds) as needed
Preferred Skills & Experience:- Master's degree in mechanical, or biomedical engineering or related field
- Previous experience in launching commercial highly regulated (Class III) medical implants or devices in a design control environment
- Previous experience in industrial design, human factors, ethnographic research, process mapping, or usability is desirable Hands-on experience working with the manufacturing processes of absorbable polymers or scaffolds is a plus
- Previous experience working with polymer based biomaterials and familiarity with their related manufacturing processes is desirable.
- Previous experience leading cross-functional project teams or being the technical lead of such teams, in a highly regulated environment is desirable, preferably in medical devices or pharmaceutical setting
- Previous experience with mechanical testing, test method development, and test method validation is desirable
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation -120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
- Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ;br>
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check
#LI-Hybrid
Required Skills:Preferred Skills:Bioinformatics, Biological Engineering, Biostatistics, Coaching, Critical Thinking, Design of Experiments (DOE), Healthcare Trends, Industry Analysis, Innovation, Medicines and Device Development and Regulation, Product Development, Relationship Building, Research and Development, Researching, SAP Product Lifecycle Management, Standard Scientific Processes and Procedures, Technologically Savvy
The anticipated base pay range for this position is :$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
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