Sr. Specialist, Product Development - RDCA

Sysmex•Mundelein, IL

4d•$110,000 - $112,000•Onsite

About The Position

Sysmex is a global leader in diagnostic equipment and information-management systems, dedicated to improving lives through science. Headquartered in Kobe, Japan, with a location in Lincolnshire, Illinois, Sysmex focuses on breakthroughs in laboratory diagnostics, information technology, workflow analysis, and life sciences. The company is seeking a Senior Specialist, Product Development - RDCA to execute product development activities for Sysmex products in the US. This role involves global collaboration with Sysmex Group, RDCA members, external vendors, and contract manufacturing organizations (CMOs), ensuring effective design controls and risk management.

Requirements

Bachelor’s degree in biology or related life sciences field required.
4-5 years of experience in R&D or Product Development in medical devices/ in-vitro diagnostics industry is required.
Exceptional verbal and written communication skills.
MS Office, including moderate to advanced PowerPoint.
Ability to interact effectively with Senior Management.
Ability to manage several projects in parallel to ensure maximum productivity, without compromising quality.

Nice To Haves

Experience in immunoassay development is preferred.
Experience in product design transfer/operations is a plus.
May include experience in the Armed Forces.

Responsibilities

Assist the Senior Project Manager to manage multiple product development projects ensuring goals are met and output is accomplished on time, and within budget, including collaborating with functional area leaders and internal and external stakeholders.
Support internal and outsourced (CMO) product development projects for the development of new and improved in vitro diagnostic products in accordance with Quality System Requirements.
Apply knowledge of IVD regulations in product development activities.
Support verification and validation testing of new products in agreement with design control requirements.
Contribute towards management of QMS processes relating to design control, design change, and design transfer.
Support design transfer of products from Product Development to Operations.
Troubleshoot problems associated with project coordination, progress, and/or objectives.
Work across the Sysmex Group for product development activities aimed at the US market by coordinating activities with various departments.
Interact with Regulatory, Operations and Marketing to efficiently and effectively manage development, transfer and launch of diagnostic products.
Other duties as assigned.