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:

 

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. 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. Apply knowledge of IVD regulations in product development activities.4. Support verification and validation testing of new products in agreement with design control requirements5. Contribute towards management of QMS processes relating to design control, design change, and design transfer.6. Support design transfer of products from Product Development to Operations7. Troubleshoot problems associated with project coordination, progress, and/or objectives.8. Work across the Sysmex Group for product development activities aimed at the US market by coordinating activities with various departments9. Interact with Regulatory, Operations and Marketing to efficiently and effectively manage development, transfer and launch of diagnostic products.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.