IVD Product Development Lead

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

Job summary

Sysmex America, Inc. in Mundelein, IL is seeking a Senior Specialist in Product Development for the RDCA group.

You will drive development activities for US products, collaborating with global teams, vendors, and CMOs to ensure design controls and risk management are integrated throughout the lifecycle. The role requires a biology or life sciences background and 4–5 years in R&D/PD in medical devices or IVDs, with strong communication and project management skills.

Qualifications

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

Responsibilities

• Coordinate execution of product development activities for Sysmex US products.
• Support development projects including design controls and risk management.
• Apply knowledge of IVD regulations in product development.
• Support verification and validation testing per design control.
• Contribute to QMS processes related to design control.
• Support design transfer to Operations.
• Troubleshoot project coordination issues.
• Coordinate across Sysmex Group for US market development.
• Interact with Regulatory, Operations, and Marketing for launches.
• Other duties as assigned.

Skills

Verbal/written comm

Project management

Stakeholder mgmt

Education

Biology degree

Tools

MS Office

PowerPoint

Job description

Sysmex America, Inc. in Mundelein, IL is seeking a Senior Specialist in Product Development for the RDCA group.

You will drive development activities for US products, collaborating with global teams, vendors, and CMOs to ensure design controls and risk management are integrated throughout the lifecycle. The role requires a biology or life sciences background and 4–5 years in R&D/PD in medical devices or IVDs, with strong communication and project management skills.