Sr. Specialist, Product Development - RDCA

Sysmex America, Inc; Mundelein (IL); Sur place; USD 110 000 - 112 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Verbal/written comm

Project management

Stakeholder mgmt

Formation

Biology degree

Outils

MS Office

PowerPoint

Description du poste

Sr. Specialist, Product Development - RDCA

Job Location(s): US-IL-Mundelein

# of Openings: 1

Job ID: 2026-4882

Category: Research and Development

Travel: Occasional (11-25%)

Overview

Find a Better Way...

...to use your skills and experience.

This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.

...to improve the lives of others.

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.

...to build a promising future.

Responsibilities

We currently have a great opportunity available for a Senior Specialist, Product Development - RDCA. The Senior Specialist, Product Development, is responsible for the execution of product development activities for Sysmex products in the US. The Senior Specialist will work globally with Sysmex Group, RDCA members, external vendors and contract manufacturing organizations (CMO); and ensure effective design controls and risk management activities.

1. 1. The Senior Specialist will assist the Senior Project Manager to manage multiple product development projects ensuring goals are met and output is accomplished on time, and within budget. This will include collaborating with functional area leaders and internal and external stakeholders.
2. 2. 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.
3. 3. Apply knowledge of IVD regulations in product development activities.
4. 4. Support verification and validation testing of new products in agreement with design control requirements
5. 5. Contribute towards management of QMS processes relating to design control, design change, and design transfer.
6. 6. Support design transfer of products from Product Development to Operations
7. 7. Troubleshoot problems associated with project coordination, progress, and/or objectives.
8. 8. Work across the Sysmex Group for product development activities aimed at the US market by coordinating activities with various departments
9. 9. Interact with Regulatory, Operations and Marketing to efficiently and effectively manage development, transfer and launch of diagnostic products.
10. 10. Other duties as assigned

Percentage of Travel: Occasional (11-25%)

Physical Risk: Regular exposures to risk that may require special training and precautions.

Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.

Mental/Cognitive Requirements: Moderate cognitive demands- Requires sustained attention, ability to prioritize tasks, and adapt to changing conditions. Involves interpreting information, solving problems, and making routine decisions.

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

The salary range for this role is $110-$112K. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.