Senior R&D Manager

1 month ago

Franklin Lakes, United States Cypress HCM Full time

A nationwide medical device client is looking to hire a Senior Manager in Franklin Lakes, NJ. This Senior Manager will be a key contributor on their R&D team within the Medication Delivery Solutions group. The individual is sought to build and lead a world class organization accountable for product development from concept through market launch and product lifecycle engineering to meet worldwide Medication Delivery Solutions - MDVC business objectives. The R&D Sr. Manager is responsible for ensuring technical excellence and for driving/making R&D decisions on product and process changes as well as to effectively select, develop, organize, and motivate a staff of highly skilled scientists and engineers.


Required Qualifications and Experience:

  • Bachelor’s Degree in Mechanical Engineering or Biomedical Engineering
  • 12 years of experience in medical device or other regulated industry.
  • At least 2 years in a supervisory role with portfolio prioritization / management responsibility.
  • Design verification and validation.
  • Research and development
  • Demonstrated capability in product development.
  • Understanding and demonstrated track record of Quality & Regulatory compliance.
  • Development and qualification of functional / dimensional measurement systems


Duties of Role:

  • Effectively recruit, select, develop, organize, and motivate a staff of skilled associates globally.
  • Demonstrate strong and clear accountability for the group's development, performance, and results.
  • Be accountable for improving and further developing processes and best practices for the PLE (Product Lifecycle Engineering) portfolio management.
  • Ensure regular updates are provided to the leadership team on the PLE portfolio.
  • Periodically interface with the platform leaders to ensure projects are selected & prioritized per business goals.
  • Be accountable for the successful execution of Product portfolio (e.g. the business platform priority list).
  • Leads new project proposal review, valuation, classification, and platform prioritization.
  • Align dedicated resources cross-functionally to optimize and ensure execution success.
  • Ensure implementation & maintenance of "scaled" phase gate product development processes.
  • Customer, sales, WW manufacturing, and OEM support.
  • Actively participate in the global ACR process to ensure Design Control compliance.
  • Support development & maintenance of detailed budgets in accordance with project, department, and business objectives.
  • Ensure efficient and effective transition of product development programs to high volume manufacturing in locations throughout the world.
  • Identify, assess, and develop state-of-the-art organizational capability in:
  • Platform portfolio prioritization, selection and execution.
  • Project leadership, communication, & escalation.
  • Transfer function continuous improvement & change control.
  • Six Sigma (DFSS) gate reviews for PLE projects.
  • Productivity metrics to constantly measure performance.
  • Requirements and risk management.
  • Critical parameters management.
  • Test method development.
  • Product verification and validation.
  • Align dedicated and shared resources cross-functionally to optimize and ensure success of new product development.
  • Engage in detailed review of cross-functional plans and be accountable for their success.
  • Perform periodic reviews of progress against plans.
  • Ensure plans are executed appropriately within department.
  • Be accountable for timely completion of al development deliverables as specified.
  • Develop and apply innovative approaches to ensure best outcomes in all aspects of the role creating an environment in which innovation can flourish through empowerment, encouragement, and support.
  • Ensure compliance with quality policies, procedures, and practices.
  • Ensure compliance with all local, state, federal, and safety regulations, policies, and procedures.


Salary of $170K annually

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