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
