Design Controls Engineer Consultant II
Location: San Diego, CA
Duration: 6 months
Knowledge of Medical Device Design Controls (MDD/MDR 2017 and ISO 13485:2016) Experience with creating and updating Design History Files (DHF's). Experience with Electronic DHF's preferred Generating test protocols, analyzing test data, and generating written reports Ability to work in a team environment to ensure conducive working relationships. Demonstrate organizational and interpersonal skills working in a cross-functional, regulated environment Ability to organize and prioritize workflow in order to meet established time frames and schedules. Proficiency in Microsoft Word, Excel, Powerpoint
Description: EU MDR R&D Engineer
In this role, you have the opportunity to
As the Medical Device Development Engineer for Devices, you will apply your technical expertise to bring current and new products into Compliance with new EU Medical Device Regulations.
This is a temporary role for 6 months and may be extended.
You are responsible for
• Coordinate 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 DHF’s to achieve compliance with Regulations (specifically, EUMDR, RoHS and REACH).
• 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 DHF’s (familiarity with electronic DHF’s - ie 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
• Understanding of RoHS and REACH Regulations is preferred
• Familiarity with cardiology catheterization procedures, tools, and terminology preferred
• Ability to work in a team environment to ensure conducive 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,
• There is 0% travel required for this position.