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 https://www.jnj.com

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Process Improvement

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

About Cardiovascular

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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Purpose: The Technical Writer will support manufacturing with engineering change orders (ECO), work instructions (WI), job instruction breakdowns (JIBs), training documentation, and creating and editing of short videos to support technical procedures. This position will also support the engineering team on validation protocols and reports.

You will be responsible for:

• Develop and update process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.

• Work with the training team to develop short videos that can supplement hands on training.

• Ability to work in cross-functional teams that span global operations. Proficient in English verbal and written communication. The ability to translate WI and JIBs to and from German or work with a translator is necessary.

• Must enjoy team approach over individual contributions. Ability to be a liaison with manufacturing assemblers and engineering teams to develop and edit work instructions and assembly documentation.

• Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations. Knowledge of FDA QSR and ISO regulations required.

• Regularly report on project status and key project metrics through scorecard presentations.

• Assist engineering team to qualify and optimize processes and tooling via documentation for IQ/OQ/PQ, preventive maintenance, Gage R&R Studies, Process Capability Studies and Designs of Experiments.

• Participate in the implementation of internal corrective actions and audit findings.

• Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments related to company products.

Qualifications/Requirements

Education:

• Bachelors required in life sciences and/or writing, medical device experience preferred.

Experience and Skills:

Required:

• 2+ years of technical documentation experience

• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team

• Must be proficient in Microsoft Office Suite. Solid understanding of QMS desired.

• Willing & able to travel internationally (~5%)

Preferred:

• Medical device experience

• Knowledge of FDA QSR and ISO regulations

• Working knowledge of SAP

Other:

• Ability to be onsite minimum of 3 times per week while training

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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is :

$77,000 - $124,200

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.