The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
A Day in the Life
•Reviews Risk Management Reports and ensures they are compliant with corporate, local and regulatory requirements. •Provides guidance and/or training with respect to risk management process and documentation to ensure commonality from project to project in methods, format and content. •Leads teams in identifying mitigations and ensuring traceability of identified mitigations. •Leads changes to the Risk Management process. •Reviews Design History File (DHF) documentation against applicable procedures as well as ensuring adequate linkages between various DHF deliverables. •Partner with project leaders to schedule, structure and execute DHF reviews throughout product development process.
Responsibilities may include the following and other duties may be assigned.
Must Haves: EDUCATION REQUIRED: •Bachelor’s degree in Engineering.
YEARS OF EXPERIENCE: •7+ years experience with a Bachelors degree in engineering or 3+ years with a Master’s degree in engineering. •5+ years Quality Engineering, Risk Management, Product Development or equivalent experience. •Experience conducting and leading teams through product risk evaluations. •Experience in medical device industry preferably with exposure to design, manufacturing, auditing, regulatory requirements and international standards. •Minimum of five years regulated industry experience, preferably in the medical device manufacturing industry.
Nice to Have – (Preferred Qualifications):
•Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired. •Good understanding of technical principles, theories, and concepts in the field. •Good oral and written communication skills. •Able to handle multiple tasks/projects and manage priorities accordingly. •Able to work in a team environment. •Ability to work under general supervision. •Good oral and written communication skills. •Cross-functionally and an effective team player. •High attention to detail. •Able to handle multiple tasks/projects and manage priorities accordingly. •Working knowledge of appropriate industry standards preferred. •Able to work in a team environment and exert influence without alienating others.