Location: Maple Grove MN
Duration: 4 -6 Months+ Extendable
Co-ordinating with Quality/Design Assurance to evaluate post-market data
Generating and maintaining technical drawings and detailed design documentation
Identifying, optimizing, and implementing design/process changes on existing product and update product DHFs to achieve compliance with regulations (specifically, EUMDR)
Generating test protocols, analyzing test data, and generating written reports
Contributing to design documentation including input for the DHF and technical design reviews
You are a part of
The R&D team within the Image Guided Therapy Devices (IGTD) business group is a team that is driven to providing products and solutions, working collaboratively within and across business groups.
To succeed in this role, you should have the following skills and experience
Bachelors of Science in Engineering (Mechanical Engineering, Material Science, Plastics Engineering, or Biomedical Engineering preferred)
Minimum of 5 years of Medical Device Industry experience.
Experienced with Design Controls and Medical Device Regulations (MDD & MDR, preferably).
Experience with creating and managing product DHFs (familiarity with electronic DHFs; Agile or Windchill preferred)
Strong understanding of Design Controls (Product Requirements, Design Inputs, Design Outputs)
Experience with Solidworks and Statistical Software applications preferred
Knowledge of EU MDR 2017 and ISO 13485:2016 Regulations is preferred
Familiarity with cardiology catheterization procedures, tools, and terminology preferred
Ability to work in a team environment to ensure productive working relationships.
Demonstrate organizational and interpersonal skills working in a cross-functional, regulated environment
Strong analytical skills.
Ability to organize and prioritize workflow in order to meet established time frames and schedules.
Proficiency in Microsoft Word, Excel, Powerpoint
Regards,
Vikas