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Director, Instrumentation & Accessories R&D

Auris Health

Auris Health

Redwood City, CA, USA
Posted on Thursday, July 13, 2023
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Description

Johnson & Johnson, Robotics and Digital Solutions (RAD) group is recruiting for a Director, Instruments & Accessories R&D, located in Redwood City, CA.

Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention and general surgery. This includes the MONARCH® platform, a first-of-its-kind robotic technology indicated for bronchoscopy visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung.

Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com. 

Overview:

The Director of Instruments & Accessories R&D will have the unique opportunity to head the organization responsible for the conceptualization, development, introduction, and continuous improvement of pioneering instruments in the endoluminal robotics space.

Reporting to the Vice President of Monarch R&D, they will help to define the technology roadmap driving overall business growth in an increasingly competitive medical device environment in the fast-growing world of flexible robotics. The candidate will lead an extraordinary, multidisciplinary R&D team, assembling the talent needed for advancing flexible robotic instruments for the Monarch Platform. In addition, they will balance the commercialization of new systems while focusing on innovation including new concepts and investigational devices, filling out the product roadmap moving forward.

Core Job Responsibilities:

This critical position requires a wide application of principles, theories, and concepts in the functional engineering field plus knowledge of all related manufacturing processes. This individual must have a strong technical background in the design of medical devices and the skills needed to guide the process of creative design from input requirements and sound experimental design. This role is responsible for leading the overall instrument product development and architecture strategies that drive our products and technology towards commercialization.

  • Own functional management of the Instruments Engineering leadership team. Provide technical leadership to engineering team of 30+ engineers, and develop development goals for direct staff.
  • Identify departmental objectives and establish goals that are measurable such that outcomes can be quantified. Develop, coordinate and update staff/department on goals, objectives and time constraints of projects.
  • Generate hiring plans, budgets, and track spending.
  • Ensure that approved programs are completed on time, within quality guidelines, at or below target cost, and with strong collaboration with senior management, the customer, and the marketplace.
  • Develop an Instrument technology roadmap that is designed for future product iteration/releases and ensure that the development processes is in compliance with FDA and ISO regulations relative to design controls.
  • Collaborate with Marketing, Quality, Engineering, Regulatory, Manufacturing, Clinical, outside vendors, partners and physicians to develop the next generation of products.
  • Lead complex medical device development programs from concept through product release, as well as sustaining engineering responsibilities.
    Drive efforts in building a robust IP portfolio.
  • Champion the Company’s Credo with emphasis in team building, empowerment, accountability, creativity, and high achievement.
  • Identify and ensure compliance with the most current international technical standards. Implement and drive sound engineering processes including appropriate tools and check points.

Qualifications

  • A minimum of BS in engineering, mechanical or electrical or related field, required degree preferred.
  • Advanced Engineering degree desirable.
  • 10+ years of product development experience within a regulated industry (medical device preferred) with increasing levels of responsibility within an R&D organization.
  • Prior management responsibility for the development, end-to-end lifecycle management, and successful commercialization of high-volume single-use regulated products (medical devices preferred).
  • Track record of successfully bringing products from concept to market on schedule & within budget.
  • Management experience of cross-functional product development teams.
  • A strong background in design control is a necessity; experience in endoscopy, endoscopic instrumentation, and/or imaging catheter design is preferred.
  • Strong leadership skills coupled with an excellent management history with multidisciplinary engineering teams.
  • Proven track record of managing and coaching individual contributors and people leaders.
  • Experience solving complex technical problems while leading a multidisciplinary team of passionate individuals.
  • Prior experience leading not only the execution of new products, but also developing and coordinating the product pipeline.
  • Proven track record of process improvement and cost efficiencies.
  • Prior experience with regulatory environments – Class II devices, 510(k) submissions, Quality Systems Regulations, ISO 13485, Medical Device Directive (MDD) 93/42/EEC, and ISO 14971, preferred.
  • DOE and statistics methodology experiences are preferred.
  • Knowledge of Risk Management, Good Manufacturing Practices (GMP), and applicable Quality System Standards.
  • Ability to thrive and flourish in a fast-paced and dynamic environment.
  • Key Skills: Hands-on involvement; Judgment & decision-making skills; Organizing & planning; Interpersonal relationship & influence; Ability to balance schedule, cost & quality; Project management skills; Conflict management; Teamwork; Managing & developing others; Communication; Able to work within a diverse group; Able to work in a changing environment (flexible); Problem analysis & resolution; Technical skills; Cross functional experience; Market knowledge.

Preferred

  • Experience in leading and managing teams through the change journey in a post-acquisition setting.
  • Previous mix of experiences in late start-up and growing companies.

Other:

  • Up to 10% Occasional domestic or international travel may be required.
  • The position requires significant on-site presence.

The anticipated base salary for this position is $175,500 - $302,910.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.