Job Description

Job Description

Job Description

Summary

Applies knowledge of engineering, biology, and biomechanical principles to the evaluation, design and development of biological/chemical products and instrumentation for medical diagnostics; from initial design to market release. Designs and implements new methodologies, materials, machines, processes or products. Conducts feasibility studies of designs to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development. Plans, organizes, and conducts scientific research and development for the Bioengineering department.

Essential Duties and Responsibilities

• Develops plans for research under the direction of Bioengineering Supervisor.
• Collects data utilizing library archives, technical journals, reference sources, internet sites, and other information sources.
• Researches and develops products such as reagents, reagent systems, and biological controls in addition to instrument system development.
• Uses scientific principles to design and execute test protocols and experiments to verify and validate that designs of products and systems meet functional and performance specifications and conform to engineering design and customer requirements, documenting test results appropriately in reports.
• Plans and designs benchtop and in vitro experiments to verify or modify theoretical propositions based on research findings in related technological areas.
• Prepares reports of completed projects for publication in technical journals for use in further applied or theoretical research activities.
• Performs analysis on experimental data, appropriately documenting results and conclusions.
• Provides scientific and technical support to production, manufacturing engineering, purchasing, service and customer applications support functions when needed. Provides input for and limited editing of related customer documentation and advertising material.
• Collaborates with design engineers, project leaders, and other personnel to identify, define, and solve problems during development, testing, and support phases.
• Keeps informed of appropriate or emerging technologies and drives development and implementation of best practices that help achieve company objectives.
• Documents development activities and deliverables consistent with formal Quality Systems; including definition of product requirements, project planning, design output (production drawings, bills of materials, procedures, specifications, inspection criteria, etc.), design review, design verification and validation, control of design changes, and risk analysis.
• Coordinates and manages activities with internal and external project stakeholders throughout the design and development process and production scale up, including development of production and quality control processes and criteria.
• May provide training to internal personnel, customers, sales representatives, and distributors when required.
• Assists with related special projects when required.

Qualifications

• Bachelor's degree or equivalent in medical technology, medical device, biology, bioengineering or chemistry from a four-year college or technical school.

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