- Entry level
- No Education
- Salary to negotiate
• Lead medical device electrical/hardware development for device projects and identify resolution for progressing complex innovative device development initiatives.
• Lead activities for device development and deployment in compliance with the quality management systems in accordance with 21 CFR 820 and ISO 13485 requirements.
• Lead activities for electrical devices and software development in accordance with IEC 60601, IEC 62304 and IEC 62471.
• Support Human Factors Engineering (HFE) activities as part of device development in accordance with IEC 62366 testing.
• Pro-actively lead and support risk assessments review and/or failure mode analysis to ensure compliance with ISO 14971:2012 requirements.
• Identify and effectively communicates “Trigger Events” (any unanticipated project events that impact the business case and/or timing) to senior leaders. This includes timely communication to appropriate organizational levels of the event along with the recommended path forward and any applicable alternatives.
• Pro-actively provide “Alternatives Analysis” for acceleration opportunities and/or opportunities to improve business proposition.
• A minimum of a bachelor’s degree required.
• MS and/or PHD preferred.
• A minimum of 7 total years of experience in the consumer products or device industry is required.
• A minimum of 5 years of experience leading cross-functional teams is required.
• Proficiency in hardware development in board design, system design, test protocol preparation and execution are required.
• Proficiency in electrical safety and software development and testing in accordance with applicable standards is required.
• Proficiency in requirements gathering/analysis of device systems/ subsystems is required.
• Proficiency in evaluating risk assessments, Design FMEA and Process FMEA for device systems/subsystems is required.
• Proficiency in the support of controlled pilot manufacturing and low volume prototype manufacturing is preferred.
• Experience with Human Factors Engineering and application of standards is preferred.
• Experience with global design control and risk management compliance as part of the product development process and in accordance with 21 CFR 820, ISO 13485 and ISO 14971 respectively is required.
• Experience launching and/or supporting new products in a GMP and regulated environment (Medical Device and Diagnostics, Pharmaceutical or Consumer Product) is preferred.
• Experience with regulatory and company audits/inspection is preferred.
• Experience and the ability to lead and manage remote, matrixed teams in both global and regional environments is highly preferred.
• Global cross-functional experience across at least 2 of the following: R&D or Engineering, Supply Chain, Marketing or Finance is required.
• Experience in engaging cross-functional team members to proactively identify risk and develop creative solutions to overcome project hurdles is highly preferred.
• Driven leader with a global mindset, excellent written, verbal and executive communication skills, a demonstrated history of managing complexity and a solid understanding of the electrical device development/testing, strong business acumen, leadership, influencing, and change management skills required/preferred.
• Experience with Six Sigma/Process Excellence Tools, Training and/or Certification preferred.
• This candidate may be required to travel up to 15% of the time, domestically and internationally.
• The position will be located in Shanghai, China
Johnson & Johnson (China) Ltd. (7047)
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.