Risk Management Engineer
Company: Nesco Resource, LLC
Posted on: May 28, 2023
A Risk Management Engineer, assures new products perform the functions intended in a safe manner and in compliance with the quality system. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately identified, evaluated, controlled, and monitored. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitate organizational success by protecting patient/user safety and meeting business needs.
--- Authors product risk management plans and reports.
--- Responsible for timely deliverable completion.
--- Makes contributions to technical directions and projects through good knowledge of discipline and its
--- Supports the requirement development process and linkage to risk management.
--- Works within existing procedures to perform a range of assignments.
--- Leads preliminary hazard analysis, coordinates/lead risk assessments (FTAs, FMEAs) incorporating legacy inputs.
--- Assures and maintains traceability among hazards, risks, risk analysis, evaluations and risk controls, and verification of implementation and effectiveness of risk controls.
--- Solves potentially complex problems by analyzing possible solutions using experience, judgment and precedents.
--- Accomplishes work with a moderate level of guidance and direction.
--- Provides informal guidance to new team members.
--- Other duties as assigned by management.
Education Level & Experience
Ph.D. in Science or Engineering discipline - Less than 1 year Entry level with a PhD
Master's Degree in Science or Engineering discipline - 3 years Relevant experience with a masters degree
Bachelor's Degree in Science or Engineering discipline - 8 years Relevant experience with a Bachelors
Knowledge, Skills and Abilities
---Demonstrates potential for technical proficiency, creativity, collaboration with others and semi-independent thought.
---Hands on experience in a product risk management and technical documentation role for medical devices a plus.
---Knowledgeable in product development, requirements and regulations (e.g. 21 CFR 820, IVDR, ISO 13485) a plus.
---Strong communication skills with the expertise to explain complex information to others in a straightforward situations.
---Applies advanced technical writing skills to produce reports and documents; writes independently.
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Keywords: Nesco Resource, LLC, Tucson , Risk Management Engineer, Executive , Tucson, Arizona
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