Mechanical Engineer

Nice to have:

· Create and execute verification and validation plans, protocols and reports.

· Create or update the risk management file for the product.

· Maintain compliance to the standards and policies of the Laborie Management System, including organizational adherence to the ISO 13485 and ISO 9001 registration standards.

· NOTE: Other duties may be assigned.

· Working knowledge of medical device design control processes, design change and document change control, product lifecycles, and product verification and validation methodologies

· Experience writing test protocols, performing tests, and writing reports specifically in Verification and Validation

· Solid project management experience to drive completion of projects and practical application of a design controlled product development process.

· Experience designing and developing devices with 3D CAD; exposure to 3D printing is a plus

· Experience designing, fabrication and/or specifying of test fixtures, tooling and equipment necessary for development of disposable medical products and processes

· Demonstrated understanding or ability to understand Medical Device QMS and regulatory requirements including FDA CFR 21 820 and ISO 13485, and other applicable standards

· Demonstrated knowledge of CAPA process and root cause investigation

· Demonstrated knowledge of risk management techniques

· Ability to work independently on assigned projects

· Excellent oral communication & report, business correspondence & procedure-writing skills

· PC literacy, ability to work with basic software and spreadsheets; experienced Project tracking software (ie MicroSoft Project, SmartTrack, etc).

· Ability to be hands on and can function independently

· BS Degree in Mechanical Engineering or Biomedical Engineering Areas