Sr. Specialist, Product Development - RDCA

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

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.

Essential Duties and Responsibilities

• 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.
• 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

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.