Staff Engineer - MedTech Surgery - R&D

Johnson & Johnson Innovative Medicine • Irving, TX

6d • $109,000 - $174,800 • Hybrid

About The Position

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, aesthetics. This position is based in Irving Texas with a hybrid schedule (3 days in office, 2 days remote or as required in office).

Requirements

• Minimum of a Bachelor’s degree in mechanical or biomedical engineering or related field
• 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

Nice To Haves

• Education or Experience with polymer, chemical engineering, or material science desirable
• 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

Responsibilities

• 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.

Benefits

• 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.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior