Risk Management and Human Factors Engineer

Posting Date 3 weeks ago(11/3/2021 3:10 PM)
Requisition ID
2021-9794
Job Location(s)
Bloomington IN United States
Shift Type
First
Position Type
Full Time
Company
Cook Inc.
Category
Quality

Overview

The Risk Management Engineer is responsible for implementing and maintaining Cook’s risk management procedures to ensure that product risk is appropriately assessed, documented, and mitigated throughout the entire product lifecycle. The engineer shall also serve as the risk management representative within product development, manufacturing, remediation, sustaining, post-market surveillance, complaint, non-conformance, and/or CAPA teams.

Responsibilities

- Implement Cook’s risk management procedures throughout product lifecycle to create/update risk management documents: hazard analysis (HAs), design, process, use failure modes and effects analysis (d/p/u FMEAs), risk-benefit assessments (RBAs), risk review reports (RRRs), clinical effects analysis (CEAs).
- Provide guidance as a representative of the risk management team to other departments that need to make risk-based decisions by facilitating the implementation of Cook’s risk management procedures.
- Assess and document product risk during new product development, manufacturing, and post-market surveillance and drive continuous improvement efforts by working with associates from engineering, quality, medical affairs and regulatory.
- Help develop quality system procedures that are compliant to relevant standards and regulations including but not limited to ISO 14971, ISO 13485, 21CFR, IEC 62366, HE75, and EU MDR.
- Identify opportunities for improvement based on feedback from internal customers, as well as other users of the risk management system.
- Support development and implementation of production controls. (e.g. qualification, process capability, sampling plans, validation, etc.)
- Support investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.
- Plan, draft, review, and approve change requests as needed.
- May interface with internal or 3rd party auditors. (e.g. FDA, Notified Body, etc.)
- Perform work per external and internal quality standards.
- Interface with internal and external groups on quality-related issues.
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices and support the understanding of medical device regulations and best practices within Cook.

- Planning, scaling, documenting, and executing human factors project activities per IEC62366
- Work with cross-functional teams and provide Human Factors support through entire product development life cycle
- Define and document workflows, user-related tasks and scenarios related to product use
- Evaluate, assess, and document risks related to product use
- Design usability evaluations to ensure user interface requirements are met, risk controls pertaining to use have been applied and are effective- Manage conflict resolution as it relates to technical situations
- Plan, review, and approve change requests

Qualifications

- MS in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering with 3 years relevant experience; or BS degree in same with 5 years relevant experience.
- Expert understanding and prior implementation experience of various standards and regulations: ISO 13485:2016, 14971:2012, 21CFR, MDD, MDR preferred.
- Experience communicating (written and oral) with Notified Bodies and other regulatory agencies (EU experience preferred) preferred.
- Professional certification (e.g. CQE, CRI, Six Sigma, etc.) preferred.
- Proficiency in statistical, quality and continuous improvement methods and tools.
- Proficiency in the use of computer applications including Microsoft Office suite of products (Word, Excel, PowerPoint, Visio, Project and Outlook) is required.
- Demonstrated proficiency in decision making – preferably across a broad spectrum of Quality Engineering responsibilities.
- Experience employing project management methods and tools.
- Reading drawings.
- Strong written and verbal communication skills.
- Oral, presentation and technical writing skills.
- Strong organizational skills.
- Critical thinking and attention to detail required.

 

Physical Requirements:

- Works under general office environmental conditions, including time in manufacturing environment and biohazard lab.
- Personal protective equipment including safety glasses, lab coat and gloves may be required in some areas associated with this position.
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Occasional travel may be required.

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