Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. Hospital laboratories are our core clinical diagnostic customers. Our life science customers include pharmaceutical and biotechnology companies, universities, medical schools and research institutions. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents. For more than 75 years, our products have been making a difference in peoples lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
The Senior Systems Engineer is responsible for coordinating the risk management activities of medical devices during the development life cycle of the product.
Tasks include analyzing, evaluating, controlling, and monitoring risks to patients, users, and the environment.
As one of the members of the Development team, with support from the core and extended teams, the incumbent is responsible for completion of risk assessment and control tasks and documentation.
Specific risk management deliverables include: Risk Management Plan, Product Safety Reference, risk analysis documents (such as FMEA, FTA, and HFA), System Risk Assessment (SRA), Risk Management Report, and documents that show traceability of risk control measures to the corresponding hazards and verification/validation activities.
Updates Risk Management Files in the post launch phase whenever there is a significant design or process change.
Must be capable of working on multiple projects in a deadline driven environment.
Must have strong oral and written communication, problem solving, decision making, and organizational skills.
Proven ability to collaborate with various design/cross-functional teams and influence product development teams to drive system safety into product design.
Strong working knowledge of ISO 14971 and p
revious experience in a Medical Device Development Risk Management role.
Bachelor's degree in Engineering field with 5+ years experience.
Experienced individual contributor with considerable understanding of work concepts, principles, and practices.
Applies knowledge to achieve functional work objectives.
Typical career level for individual contributors.
Uses complete understanding and wide application of technical concepts, theories, standards, and practices in chosen field and is expanding knowledge or related disciplines.
Full knowledge of industry standards and practices.
Makes material contributions to the completion of specific programs and projects with significant scope that materially impact organizational schedules, resources, and costs.
Decisions and results have moderate impact on function resources and objectives.
Meet regulatory requirements and establish policies and procedures.
Applies analytical skills and independent judgment to develop innovative, practical and consistent solutions to a wide range of complex problems.
Works with minimal guidance and expands knowledge and skill sets beyond own area.
Danaher is a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our portfolio of premier brands is among the most highly recognized in each of the markets we serve. Danaher's portfolio is comprised of five reporting segments: Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies. Driven by a foundation provided by the Danaher Business System, Danaher's 48,000 associates serve customers in more than 125 countries and generated $13.2 billion of revenue in 2010.
North America-United States-FL-Miami
Danaher - 2 years ago
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