Principal Device Technical Owner, MSAT – Synthetics

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 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 Partsand 820 and Johnson & Johnson Policy Standards related to Good Manufacturing Practice (cGMP) for Combination Products Pharmaceuticals and Medical Devices.

Key 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

Qualifications:

Education:

• Minimum of Bachelors in Engineering degree required; advanced degree or focused degree in Mechanical Biomedical or Materials Engineering is preferred

Experience and Skills:

Required:

• 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 partor ISO 13485 (e.g. Design Control Change Control CAPA and Complaint Handling)

Preferred:

• 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

Other:

• Requires up to 25 % domestic and international travel including ability to work in an international environment across different time zones

Hybrid#

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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Coaching Competitive Landscape Analysis Critical Thinking EHS Compliance Engineering Good Manufacturing Practices (GMP) Lean Supply Chain Management Organizing Package and Labeling Regulations Package Management Process Improvements Product Packaging Design Science Technology Engineering and Math (STEM) Application Standard Operating Procedure (SOP) Sustainability Sustainable Packaging Transparency Reporting Validation Testing

The anticipated base pay range for this position is :

$102000.00 - $177100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companys 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 additional general information on Company benefits please go to: - Experience:

Staff IC