Engineer - Degree Optional IV in Maplewood, MN at Volt

Date Posted: 7/29/2020

Job Snapshot

Job Description

Risk Management Engineer (12-month contract)
St. Paul, MN

A Risk Management Engineer assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system.  They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored.  They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Responsibilities:

•      Execute and support on-time completion of Risk Management Deliverables

•      Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback

•      Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

•      Support Risk Management / Cybersecurity activities from product Concept through product obsolescence, including post-market activities and support for submissions. 

•      Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

•      Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy.

•      Complete Document Change Request Reviews in a timely and objective manner

•      Additional duties may be identified by functional management based on the current project/business objectives.

•      Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

•      Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

•      Performs other related duties and responsibilities, on occasion, as assigned.

 

Requirements:

•      Bachelor level degree in Engineering or Technical Field, advance degree preferred.

•      3 - 6 years’ experience.

•      Previous engineering/medical device experience preferred.

•      Remediation experience would be preferred.

Volt is an Equal Opportunity Employer