Staff Engineer, Product Risk Management - 2406187686WDescriptionJohnson & Johnson Surgical Vision Inc. a member of the Johnson & Johnson family of companies, is recruiting for a Staff Engineer, Product Risk Management, located in Irvine or Milpitas, California!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/ .In this role you will be part of the Johnson & Johnson Vision Lifecycle Management and New Product Introduction Quality Engineering team! You will have responsibilities in planning, implementing, execution, standardizing, coordinating, and managing Risk documentation for Surgical Vision products. This role is responsible for Vision products excluding Contact Lenses and CEH (Consumer Eye Health) solutions.Key Responsibilities:
Provides the ongoing maintenance of the Risk Management files for current marketed product in accordance with all applicable laws/regulations and Corporate Johnson & Johnson, procedures and guidelines.
Reviews and continuously leads efforts to improve the Risk Management System for products both pre and post launch.
Maintains dashboards and other reports of performance metrics as required while providing regular updates and status reports to management.
Initiates quality event escalations as appropriate when product risk profiles change and facilitates the generation of risk documents as part of the applicable design phase within the Product Development Process.
Participates in evaluation processes as the Quality Representative, approves regulatory reports for submission to US FDA as well as other regulatory bodies, drafts response communications to inquiries from regulators and supports internal/external audits and inspections defending risk management documentation.
Remains informed of new or revised regulations and/or guidelines and assesses impact on company Risk Management processes to maintain the Risk Management System in accordance with ISO14971 and all Enterprise, MedTech and Vision Standards.
The role requires interaction with the Complaints Management team and Post Marketing Surveillance Group to provide updates to risk documents as well as collaborating with multiple teams and other departments to ensure compliance with applicable risk standards.
Works to improve the systems used within the New Product Development community ensuring compliance to existing procedures and uniformity of risk assessments performed on new products.
Responsible for conducting business meetings with other functions and communicating business related issues or opportunities to next management level.
QualificationsEducation:
A minimum of a Bachelor’s degree or equivalent in Engineering, Science or related technical field is required.
Experience and Skills:Required:
At least six (6) years of related experience, including significant experience working in Pharmaceutical, Medical Device or another highly regulated industry.
At least two (2) years of experience performing Medical Device Risk Management.
Critical thinking and investigation skills.
Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy.
Familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
Ability to function in a team environment and deliver on team objectives.
Strong attention to detail with demonstrated written and verbal communication skills.
Prior medical device complaint handling experience, or knowledge of medical device regulations.
Preferred:
Developed presentation skills.
Project management and/or process mapping experience.
Other:This position may be located in design centers at Irvine, CA, or Milpitas, CA and may require up to 25% domestic or international travel.The anticipated base pay range for the Irvine, CA location of this position is $104,000 to $166,750.The anticipated base pay range for the Milpitas, CA location of this position is $119,000 to $191,820.
Employees and/or eligible dependents may be 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.
Employees may be 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.
Employees are eligible for the following time off benefits:
– Vacation – up to 120 hours per calendar year– Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year– Holiday pay, including Floating Holidays – up to 13 days per calendar year– Work, Personal and Family Time - up to 40 hours per calendar yearFor additional general information on Company benefits, please go to:
https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on May 29, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .Primary Location NA-US-California-IrvineOther Locations NA-US-California-MilpitasOrganization Johnson & Johnson Surgical Vision, Inc (6234)Travel Yes, 25 % of the TimeJob Function R&D Process EngineeringReq ID: 2406187686W