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Job Description:

We are searching for the best talent to join our team as a Sr. Principal Engineer, R& D located in Raritan, NJ.

Purpose: This individual will lead efforts to streamline Design Control and other SOPs, balancing flexibility, efficiency, and speed, while adhering to applicable medical device industry regulations. This person will represent R& D for system and process initiatives, such as the implementation of new Product Lifecycle Management (PLM) and Risk Management systems across R& D. The role will require the ability to collaborate across functions, be proficient in change management, and train the organization, as needed. Additionally, this person will provide updates to inform senior management, as needed.

This role will guide colleagues through consultation and mentoring in Design Controls, business systems, and processes, and will integrate Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this role are:

• Lead the management, development, and communication of key, design-related processes associated with new product development and lifecycle management.
• Serve as the primary subject matter expert and overall owner for design controls processes.
• Practically and strategically apply current and emerging regulations into the design controls system.

• Develop, implement, and maintain design control processes and systems to continuously improve product development and meet organizational goals. These processes and systems should be effective, efficient, and compliant to applicable standards / regulations, both external and internal.
• Serve as the Design Controls Champion within the local quality management system, owning applicable standard operating procedures (SOPs), and delegating said ownership to others as appropriate. Then, distribute these SOPs via organized and maintained training curricula.
• Provide direct training and support to stakeholders to ensure project execution remains within the design controls framework.
• Represent R& D during audits and collaborate with other business functions to lead resolution to audit findings and corrective / preventive actions, e.g. Risk Management, Quality Engineering, Supply Chain, Quality Systems, Compliance, and Regulatory Affairs.
• Identify and pursue design control system improvement opportunities, benchmarking best practices where appropriate. Escalate design control risks and issues that may impact business decisions.
• Onboard and optimize partnerships with external design service providers to accelerate the use of technology to improve design controls, business process flows, and product definition.
• Support the design control portions of business integrations and acquisitions.
• Perform other duties assigned, as needed.

Education:

• Bachelor’s degree in a related engineering, business, or quality discipline

Required Skills & Experiences:

• 8+ years of experience working within a quality management system
• Familiarity with quality management systems from 2+ companies / industry environments
• 5+ years in a collaborative role with a background in Product Development, Supplier Management, Customer Service, Quality Engineering, or Quality Systems
• 5+ years of experience working in the medical device industry
• Good working knowledge and understanding of medical device regulations, standards, and regulatory bodies, e.g. FDA (Food and Drug Administration), ISO (International Organization for Standardization, and MDR (EU Medical Device Regulation).
• Familiarity with design controls, procedure development, and applicable tools, e.g. FMEA, fault tree analysis, and risk severity / likelihood processes.
• Strong working knowledge of good audit practices and review of DHFs (design history files).
• Working knowledge of requirements management software, product configuration management systems, PLM systems, and CMII Compliance.
• Success in simultaneously managing multiple and competing projects.

Preferred Skills & Experiences:

• Strong communication skills (both written and verbal) to personnel at all levels of the organization.
• Strong workshop facilitation skills
• Conflict management skills
• Ability to develop and lead training programs.
• Strong project management skills.

Other:

• This position may require up to 20% domestic and international travel

The anticipated base pay range for this position is [$173, 500] to [$235, 000]

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on company benefits, please go to: - https: //www.careers.jnj.com/employee-benefits

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.