Job Description

Engineer I or Engineer II | Direct Hire | Maple Grove, MN | Medical Device Industry



A well known medical device company in Maple Grove is seeking an Engineer I or Engineer II to help perform equipment validations (IQ OQ PQ) and Software validations. This person would be in a hybrid role (3-4 days onsite to perform equipment validations, but if there's documentation that needs to be done, you can do it from home).



* Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.

* Provide project estimates independently.

* Submit specification, protocol and report for approvals and documentation control via a Change Request.

* Develop comprehensive software validations and/or equipment qualification protocols per the specification.

* Execute software validation and/or qualification protocols & record results.

* Document, communicate and follow-up on software/equipment issues.

* Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.

* Create documents, links and Change Requests utilizing a Product Data Management system.





Qualifications:



BS or MS: Engineering realm

1-5 years' experience as an Engineer

IQ, OQ, PQ experience (equipment validation) & Software validation experience REQUIRED!!



Open to an Engineer I or Engineer II, NOT Sr. level