20 days old
2018-06-252018-07-25

Senior Manager, Research & Development, Kalila

Terumo
Campbell, CA
  • Job Code
    401590
JobId: 401590
JobTitle: Senior Manager, Research & Development, Kalila
Department: KMI R&D
Location: Campbell
Description:
Job Summary: 
This position is responsible for leading the Research & Development team, ensuring a structured and interdisciplinary development approach from concept to production.  Senior Manager, Research & Development considers both the business and the technical needs of all customers with the goal of providing a quality product that meets all user needs and requirements.  This role is the technical conscience of the project ensuring the product design intent is maintained through-out the project, and more broadly will also create a consistent approach and support across all new product development projects. Through direct reports and cross-functional members, ensures that all products are designed and developed and manufactured in compliance with the company Quality System, budgetary requirements and the regulatory requirements of the countries into which the products will be marketed.
Senior Manager, Research & Development will actively collaborate with senior staff, upstream marketing, and customers to determine needs in product design, product enhancement, user interface, and possible integration of product with other medical systems or products. 
Job Details
1. Technical and Program Management: Collaborate with upper management on new product development strategy and decisions. Provide cross-functional leadership and oversight on new product development projects. Coordinate multiple project team activities through all phases of development.   
a. Provide initial stage project planning, schedule, resource requirements, and strategy of new product development projects. 
b. Create, maintain, and manage overall project schedule, and ensure that critical timelines and\/or budgets are established and met.  
c. Perform as a Technical Lead on multiple projects to lead and implement the strategic plan involving coordination with other departments. 
d. Ensures that all phases of projects are documented and handled in accordance with Quality System requirements and regulatory requirements of the countries into which the products will be marketed.
e. Collaborate with regulatory affairs to determine regulatory path strategy. 
f. Collaborate with Operations to determine strategic production support in-house and\/or via a contract manufacturer.
g. Projects & tasks to be completed include organizing and leading members of the project team, planning and scheduling activities, and coordinating resources. 
h. Conduct project team meetings across multiple project teams to ensure communication between multi-functional team members.   
i. Establish project time lines and staffing needs based on product development programs.  
j. Monitor progress of all departments and ensure all areas are managed in accordance with company objectives, budgetary requirements and legal requirements.
k. Monitor the recruitment and retention of appropriate staff in accordance with company needs and governmental requirements.
l. Provide proactive management and leadership to staff including team building and mentorship. 
m. Develop positive proactive working relationships with team members and other staff. 
2. Project Engineering:  Provide engineering leadership in the design, development, and completion of market release requirements for a project.  This may include feasibility studies, designing & implementing evaluations and providing technical input for justification of project and design.  
a. Coordinate product specification, customer requirements, and other design input development with the cross functional team by considering the needs of all customers and stakeholders, internal and external.
b. Develop detailed specifications and manage pre-clinical trials for new products or current product enhancements.  
c. Define strategy for product testing plans and protocols. Provide engineering rationale and justification for results. These reports could be submitted to the FDA to support new product clearance or claims.
d. Prepare & lead technical design reviews to a cross-functional and technical team. 
e. Contribute to the DHF and regulatory submittals, collaborating on SOPÙs, and completing necessary documentation for completion of design control and\/or regulatory submission. 
f. Prepare and present product designs, production processes and related activities to upper management. 
g. Ensure that product documentation is in accordance with Quality System requirements design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control and design control requirements.  
3. Regulatory Compliance:  Ensure engineering testing and documentation is in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies. Support regulatory submissions by collaborating with regulatory affairs representative and providing technical support and response to the agencies. 
4. Customer  Interface:     Work directly with customer representatives, Marketing and Sales staff, to determine needs in product design, user interface, and possible integration of product with other medical systems or products.  Work with physicians and observe clinical cases to obtain input on product designs and enhancements. May provide user training and contribute to the development of support materials as required. 
5. Responsibilities to the Quality System:  
a. Support the Quality System and Quality Policy.  
b. Provide feedback to improve and enhance the quality system.
c. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  
d. Assure knowledge of Quality System procedures and requirements, including regulatory requirements, training requirements for position activities. 
e. Ensure subordinate staff are trained in applicable procedures prior to performing Quality-related activities. 
f. Inform responsible personnel of concerns involving product quality.
6. Intellectual Property:  Ensures technical activities are properly documented in lab notebook. Participates in and contributes to technical discussion sessions to generate new intellectual property.
7. Safety:   Performs job functions in a safe and effective manner.   Ensures that employees under position supervision are adhering to the safety procedures of the company.

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Senior Manager, Research & Development, Kalila

Terumo
Campbell, CA

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Terumo
Campbell, CA

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