Staff Engineer - MedTech Surgery - R&D

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 Surgery Fueled 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 https://jnjmedtech.com 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 www.mentorwwllc.com 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