Senior Product Development Specialist—IVD/RDCA

Sysmex Corporation; Mundelein (IL); On-site; USD 110,000 - 112,000; Full time

Benefits offered by this job

Health plan

Annual bonus

Paid time off

Parental leave

Bereavement leave

401(k)

Job summary

Sysmex, headquartered in Kobe, Japan, with a presence in Lincolnshire, Illinois, seeks a Senior Specialist, Product Development - RDCA to execute product development activities for US markets. You will collaborate with Sysmex Group, RDCA members, external vendors and CMOs to ensure robust design controls and risk management.

The role involves managing multiple projects, applying regulatory knowledge, and supporting verification, validation, and design transfer activities across global teams.

Qualifications

• Bachelor’s degree in biology or related life sciences field.
• 4-5 years of experience in R&D or Product Development in medical devices/ in-vitro diagnostics required.
• Experience in immunoassay development preferred.
• Experience in product design transfer/operations a plus.

Responsibilities

• Assist the Senior Project Manager to manage multiple product development projects on time and within budget.
• Support development projects for new and improved in vitro diagnostic products.
• Apply knowledge of IVD regulations in product development activities.
• Support verification and validation testing per design control requirements.
• Contribute to management of QMS processes relating to design control, design change, and design transfer.
• Support design transfer of products from Product Development to Operations.
• Troubleshoot issues in project coordination and progress.
• Coordinate activities across Sysmex Group for US market development.
• Interacts with Regulatory, Operations and Marketing to manage launches.

Skills

Verbal communication

Written communication

Project management

Education

Bachelor’s degree in biology or related life sciences

Tools

MS Office

PowerPoint

Job description

Sysmex, headquartered in Kobe, Japan, with a presence in Lincolnshire, Illinois, seeks a Senior Specialist, Product Development - RDCA to execute product development activities for US markets. You will collaborate with Sysmex Group, RDCA members, external vendors and CMOs to ensure robust design controls and risk management.

The role involves managing multiple projects, applying regulatory knowledge, and supporting verification, validation, and design transfer activities across global teams.