Advance your career with Mindlance! We have been connecting talented IT professionals with world-class companies since 1999. Mindlance is here to help you to find the perfect fit with just the right company. Currently, we are seeking a Quality Engineer, New Product Development (NPD) and Sustaining Product for an exciting career growth opportunity.
Make your next big career move with the kind of position that will allow you to be genuinely passionate about the work you do! Our recruiters will work closely with you to help you get the edge over the competition. Let Mindlance advocate for you apply today!
Bio-surgical Medical device sustaining related project to ensure we address the business needs in a cost effective and complaint manner. Engineer will be responsible for sustaining the products in the field in compliance with the quality system and technical expertise. Hands on experience with product development and Processing of change controls, designing, developing, implementing and evaluating optimal, cost-effective projects and technologies.
Must have experience or advanced training and demonstrate proficiency in change controls, Investigations, problem solving, statistical methods, DHF remediation, Risk file remediation, problem analysis and resolution, materials science, design of experiments etc.
Good understanding of EUMDR remediation; extensive cross-functional team experience, including technical and non-technical work.
Completely proficient in relevant products development processes in compliance with FDA design control 21CFR820.3 and ISO13485
Understanding 21CFR600 is also preferred
Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
Ability to manage routine small projects without assistance.
Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements
Strive to be compliant and have Big picture understanding
Knowledge of the basic principles in various engineering disciplines.
Must have initial training in concepts of: Six Sigma & Quality techniques
Must know how to coordinate with cross functional team and open to learning quickly and aligning on big picture
BS in Engineering (discipline: Mechanical, Biomedical preferred)
3-5+ years of recent and relevant experience
Design Control Elements
Risk Management Elements
Software: Trackwise8 proficiency, Word, Excel, Visio, PowerPoint, Outlook
Change Control TW8 system experience
Preferences: good communication skills written and spoken
Interview platform: phone / video WebEx
Intake notes (key experience you would like to see on resumes):
Product focus: Medical Surgical Tools: implantable, Bio surgical device and Biologics.
Emphasis more on DHF remediation, Risk File remediation/creation and processing of change controls.
3-5+ years of recent and relevant experience in medical device industry experience (Pharma is not transferable). Medical Device Class II & III experience.
BS in Engineering (discipline: Biomedical, Mechanical preferred)
Software: Trackwise8 proficiency, Word, Excel, Visio, PowerPoint, & Outlook
Quality Engineer, New Product Development (NPD) and Sustaining Product
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