R&D Technician II

Nextern•Maple Grove, MN

4h•Onsite

About The Position

The R&D Technician II will be responsible for hands on development work including, but not limited to, prototype to pilot manufacturing of new and novel medical devices including implantable devices and catheters. They assist with ongoing training, development, and accountability of all team members. Working at Nextern is a better kind of work. We look for people who can exercise their personal superpowers while living our company principles. At Nextern, we are all responsible for making a meaningful impact on day to day patient quality of life. Our unique energy is unmistakable as we have fun, care about one another, and build a place we can all grow & produce great work. Come join Nextern, where we are in it TOGETHER!

Requirements

Must be self-motivated with ability to handle, organize. and prioritize multiple tasks and able to perform under pressure to meet deadlines.
Abile to effectively build and maintain relationships, communicate, and interact within a nimble development organization (Flatarchy Organizational Structure).
Strong desire to be in the office and actively engaging with and support/serve project teams, customers, and leadership.
Quality professional with 2-5 years of hands-on experience with document management, process improvement and project management, database administration processes, or similar activities, in a regulated industry – pharmaceutical or medical device industry – with direct document control experience.
Must be well-organized and proficient at reviewing and editing documentation.
Have the ability to maintain attention to detail while executing multiple tasks.
Must be proficient in the use of office computer applications such as Word, Excel, PowerPoint, and Adobe Acrobat.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Willingness to provide and receive constructive input and feedback.
Associates degree from a community or technical college.

Responsibilities

Performs QA document control functions, including document logging, tracking, processing, review, distribution, release and archiving of documents.
Perform final manufacturing Device History Record (DHR) review at close of development, manufacturing, and product release.
Organizes and ensures accurate and reliable filing systems for all documents.
Maintains in house training programs including training matrix, training files, and annual audit of training files.
Actively participates in internal and customer audits.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure QMS compliance.
Use data collected throughout the company to analyze, trend, and report on the effectiveness of quality system processes.
Uses problem solving methodologies to identify and correct the root cause of problems. Continually drives process improvements.
Perform final manufacturing Device History Record (DHR) review at close of manufacturing process and product release.
Responsible for the site operation and maintenance of the Epicor ERP system.