Senior Specialist, IVD Product Development

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

Benefits offered by this job

Health insurance

Vision and dental insurance

Annual incentive bonus

Paid time off

Parental leave

Bereavement leave

401(k) plan

Job summary

Sysmex America, Inc. in Lincolnshire, Illinois, is seeking a Senior Specialist, Product Development - RDCA to drive US product development projects and ensure robust design controls.

You will collaborate with global teams, external vendors, and CMOs to deliver compliant, high-quality diagnostic products. The role requires 4–5 years in R&D/PD within the medical devices/IVD sector, strong communication skills, and the ability to manage multiple projects while coordinating with Regulatory,

Qualifications

• 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

Responsibilities

• Support Senior Project Manager to manage multiple product development projects, ensuring goals are met, on time and within budget.
• Support internal and outsourced (CMO) product development projects for new/improved in vitro diagnostic products per Quality System Requirements.
• Apply knowledge of IVD regulations in product development activities.
• Support verification and validation testing of new products per design control requirements.
• Contribute to management of QMS processes related to design control, design change, and design transfer.
• Support design transfer of products from Product Development to Operations.
• Troubleshoot issues in project coordination, progress, or objectives.
• Coordinate activities with Sysmex Group departments for US market product development.
• Interact with Regulatory, Operations and Marketing to manage development, transfer and launch of diagnostic products.

Skills

Project management

Verbal communication

Written communication

MS Office / PowerPoint

Education

Bachelor’s degree in biology or related life sciences

Job description

Sysmex America, Inc. in Lincolnshire, Illinois, is seeking a Senior Specialist, Product Development - RDCA to drive US product development projects and ensure robust design controls.

You will collaborate with global teams, external vendors, and CMOs to deliver compliant, high-quality diagnostic products. The role requires 4–5 years in R&D/PD within the medical devices/IVD sector, strong communication skills, and the ability to manage multiple projects while coordinating with Regulatory,