Development Scientist III - Transfusion and Transplant

Development Scientist III – Transfusion and Transplant

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The Assay Development Scientist III performs a variety of tasks, including supervisory activities, associated with the development of new products and new manufacturing processes. This includes investigation into and implementation of product and process changes, and the transfer of new products and processes to the manufacturing departments. The role oversees and provides leadership to cross‑functional development teams in developing new products using design controls, and works at strategic and tactical levels by identifying resources for the department, including facility, equipment, personnel, and budgetary requirements.

• Performs activities associated with the development/launch of new products and development/implementation of new manufacturing processes
• Performs departmental activities according to department procedures and/or supervisory instructions
• Completes tasks within procedure‑ or department‑defined time frames
• Performs specified supervisory activities as directed by departmental management
• Participates in developing departmental procedures, quality plans/device master records, and/or work instructions
• Implements special projects and validations, as needed
• Participates in training and the development of employee skills
• Performs administrative functions to ensure the appropriate day‑to‑day departmental operations
• Participates in procuring facility, equipment, personnel, and budgetary resources required by the department
• Participates in forecasting future departmental needs for equipment/capital
• Participates in departmental internal audit process
• Ensures department records are legible and stored according to procedure/work‑instruction‑defined protocols and time frames
• Follows applicable laboratory OSHA regulations with respect to chemical hazards, blood‑borne pathogens, safety, etc.
• Understands ANSI/ISO/ASQC Q9001, 21 CFR 1–99, 200’s, 800’s, 600’s, and EN46001 standards as applied to corporate quality system
• Understands source, composition, and characteristics of products and associated chemical and biosafety hazards
• Follows applicable company procedures for the documentation of training of employees
• Interacts cooperatively with coworkers, managers, and employees of other departments. Receives direction well from superiors

Works closely with other R&D groups, Systems Engineering, Quality, Regulatory, MTS, and occasionally Marketing and Clinical teams.

• Doctoral degree (PhD) or equivalent combination of education and experience
• Four to ten years of related work experience
• Experience in IVD development (assay focus) required
• Science or Engineering degree

• Excellent written and verbal communication skills.
• Excellent analysis, troubleshooting, and debugging skills.
• Ability to perform in a fast‑paced, agile environment.
• Ability to operate independently and exercise good judgment.
• Understanding of technical content and the ability to communicate well with subject matter experts.
• Works well with others in a collaborative, goal‑driven environment.
• Ability to read, analyze, and interpret common scientific and technical journals.
• Ability to respond to common inquiries and complaints from customers and regulatory agencies.
• Ability to effectively present information to management.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

N/A

Senior level:
Mid‑Senior level

Employment type:

Full‑time

Job function:
Research, Analyst, and Information Technology

Industry: Medical Equipment Manufacturing