Director of Product Development / Flow Cytometry

Employer
IncellDx
Location
San Carlos, CA
Posted
Jun 04, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Job Description: Director of Product Development/Flow Cytometry

The Director of Product Development develops IVD molecular and companion diagnostic products and leads group work to develop new cytometric applications for lncellDx technology.

Responsibilities

  • Integrate IncellDx technologies into marketable products that comply with all quality and regulatory requirements and with company strategic goals. 
  • Oversee new product development from the start of feasibility and initiation of Design Controls through product launch; oversee transfer of OEM products into the IncellDx quality system. 
  • Manage R&D group work supporting new product design and development, verification and validation. 
  • Foster the use of project management methodologies and tools as needed to implement new product introductions. 
  • Oversee external collaborations.
  • Review and approve company SOPs, investigations of non-conformance, CAPAs, complaints, Supplier Qualifications, and Quality Agreements.  
  • Collaborate with manufacturing, operations, and quality departments to ensure accurate transfer of product design to production and to establish Device Master Record.
  • Support on-going manufacturing and field operations by performing investigations and trouble¬≠shooting as needed.

Minimum Qualifications

  • MS in molecular biology, biochemistry or related field
  • Minimum 3-4 years experience with molecular diagnostic product or clinical assay development
  • Experience working in an FDA-regulated industrial setting
  • Experience planning and leading verification and validation activities in the medical device industry. 
  • Experience developing product requirement specifications in accordance with customer needs and product concepts. 
  • Technical proficiency in cellular and molecular biology, cell culture, and/or virology 
  • Excellent analytical and problem-solving abilities; working knowledge of statistical analysis techniques 
  • Excellent written and verbal communication skills
  • Comfortable in a quick paced environment, able to shift priorities when needed