Sr. Principal Engineer, R&D

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:

R&D Product Development

Job Sub Function:

Multi-Family R&D Product Development

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America

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