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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:

Quality

Job Sub** **Function:

R&D/Scientific Quality

Job Category:

People Leader

All Job Posting Locations:

Athens, Georgia, United States (inactive), Bridgewater, New Jersey, United States (inactive), Cincinnati, Ohio, United States of America, Cornelia, Georgia, United States of America, Danvers, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, Irvine, California, United States of America, Irving, Texas, United States of America, Jacksonville, Florida, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Palm Beach Gardens, Florida, United States of America, Plymouth, Minnesota, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, San Angelo, Texas, United States of America, Santa Clara, California, United States of America, Spring House, Pennsylvania, United States of America, Tampa, Florida, United States of America, Titusville, New Jersey, United States of America, Warsaw, Masovian, Poland, West Chester, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is recruiting for a Director, Design Quality Engineering in Heart Recovery located in Danvers, MA with considerations given to other J&J MedTech site locations in the US.

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/ .

The Director Design Quality Engineering Digital Patient Solutions will be an integral cross functional partner in new product development within this newly created digital platform for Abiomed. This position will focus on growing and developing the digital quality engineering team to further accelerate innovation. This director will utilize their experience to enhance existing quality processes focused on cybersecurity, artificial intelligence, machine learning, hardware development, and cloud data management. Maintaining & accelerating the existing new product launch cadence through partnerships both internally and externally is key to success.

This role will shape the Digital strategy at Abiomed by establishing quality system processes to efficiently develop machine learning and AI into our future products. Additionally, this director will establish quality strategies to partner with third party digital partners and establish streamlined ways to interact with external quality systems.

This is an exciting opportunity to become part of the fast paced, innovative Abiomed team with significant focus on growing our digital portfolio over the near term as part of our newly created Digital Patient Solutions platform! www.heartrecovery.com

Responsibilities

+ Launch and stabilize new products through concept, design, development, and steady-state processes with responsibility for hardware and software quality and compliance within our newly created Digital Patient Solutions (DPS) platform.

+ Lead and mentor direct reports to execute new product development activities and MedTech integration strategies.

+ Drive the development of digital solution products by establishing requirements, performing risk assessments, and developing verification and validation strategies.

+ Develop agile quality processes to support machine learning, cloud data management, and artificial intelligence in regulated medical device applications.

+ Execute quality system improvements to ensure compliance to emerging global medical device software & product security regulations;

+ Work with partners to build and review test plans and artifacts such as design documents, verification tests, system integration tests during the development, manufacture and support of medical device hardware and software release.Act as quality audit lead for quality system processes related to software and hardware new product development.

+ Maintaining compliance to all applicable medical device, risk management, software, electrical safety, and cybersecurity standards.

Required

Minimum Education: BS in engineering, computer science, information technology or relevant science/technical field

Years of Related Experience: 15 Years

Knowledge, Skills and Abilities:

+ Experience in medical device, aerospace, defense or similar highly regulated industry

+ Knowledge and experience applying IEC 62304 and ISO13485

+ Proven knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of growing complexity

+ Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms

+ Knowledge and experience in application of product security standards.

+ People Management Experience:

+ Supervisory experience or experience in managing/directing work teams (in Quality Engineering, Quality Systems, Quality Assurance, Risk Management, or New Product Development)

Preferred

Education: MS or Advanced Degree

Area of Study: Engineering, computer science, information technology or relevant science/technical field

Related Industry Experience (if applicable): Medical Device Software, Risk Management, Cloud Data Management, Cybersecurity, Artificial Intelligence, & Machine Learning (ML)

Knowledge, Skills and Abilities:

+ Experience in developing and commercializing AI/ML based technologies

+ Knowledge of cloud-based data management and software deployment

+ Experience in maintaining compliance to cybersecurity standards

+ Development of medical device hardware in compliance with IEC 60601

+ Experience in implementing and maintaining quality system procedures

+ Lean/Six Sigma/Design Excellence Black Belt Certification, or equivalent

+ ASQ Certified Quality Engineer and/or Certified Manager of Quality/Organizational Excellence

Travel on the Job:

+ Travel Percentage to not exceed 25%; Primarily Domestic (Danvers, MA), some potential for international travel