Director of Product Development / Flow Cytometry
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.
- 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 troubleshooting as needed.
- 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