Principal Device Technical Owner, MSAT – Synthetics

Johnson & Johnson Innovative Medicine • Horsham, PA

1d • Hybrid

About The Position

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: Supply Chain Engineering Job Sub Function: Packaging Design Engineering Job Category: Scientific/Technology All Job Posting Locations: Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Principal Device Technical Owner, MSAT (Manufacturing Science and Technology)– Synthetics ! This position is located (onsite/hybrid) in Titusville, NJ. Alternate locations may be considered in Beerse, Belgium; Latina, Italy or Schaffhausen, Switzerland. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States, Puerto Rico- Requisition Number: R-072257 Belgium, Italy - Requisition Number: R-073358 Switzerland - Requisition Number: R-073346 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Position Summary: Our Principal Device Technical Owner will be responsible for the ongoing lifecycle engineering and technical support of the device constituent for combination products in Johnson & Johnson Innovative Medicine. This engineer will transition the responsibilities from development to manufacturing and take accountability for technical support including change control assessments, process improvements, complaint investigations, CAPA and audit support as required. This person will be the key point of contact to site operations and quality leadership for their area of responsibility. The Principal Device Technical Owner will ensure all validation activities and ongoing production conducted at suppliers, external manufacturers and internal manufacturing and assembly sites are in compliance with all applicable procedures and to the requirements of 21 CFR Parts 3, 4,11, 210, 211 and 820 and Johnson & Johnson Policy Standards related to Good Manufacturing Practice (cGMP) for Combination Products, Pharmaceuticals, and Medical Devices.

Requirements

• Minimum of Bachelor’s in Engineering degree required; advanced degree or focused degree in Mechanical, Biomedical, or Materials Engineering is preferred
• Minimum 8 years of relevant work experience
• Experience in design and development of Medical Devices, Combination Products, or packaging processes in the Medical Device, Biomedical, or Pharmaceutical industries
• Experience in equipment design, qualification, and validation
• Proven interpersonal communication skills, and ability to collaborate with external suppliers, contract manufacturers, and global partners
• Demonstrated compliance experience with one or more of the following is required: FDA CFR part 3, 4, 210, 211, 820, or ISO 13485 (e.g., Design Control, Change Control, CAPA, and Complaint Handling)

Nice To Haves

• Knowledge in plastic injection molding or metal materials and processing technologies
• Experience in leading global project teams or certification in project management
• Experience with cleaning validations
• Strong analytical problem solving skills and knowledge in applied statistics and statistical process control
• Six Sigma Black Belt Certification
• Experience with financial analysis and business case development

Responsibilities

• Lead device assembly design transfer, including process and equipment qualification (IQ/OQ/PQ), validation, and commissioning activities
• Lead development of manufacturing strategy, equipment User Requirements and process Failure Mode and Effects Analysis (pFMEA)
• Lead process design and characterization studies
• Develop and qualify additional capacity for sub-assembly and assembly processes per manufacturing network strategies for the production of devices
• Support assembly sites in solving technical issues
• Lead or contribute to the improvement of processes and quality systems in support of combination products and the device constituents of combination products
• Effectively perform root cause investigations and write technical documents

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

What This Job Offers

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