Validation Engineer Consultant--Mechanical

USDM Life Sciences Bothell, WA
USDM Life Sciences is a leading global consulting firm focused on life sciences, specializing in regulated business processes, with an emphasis on compliance and performance. We are seeking a V&V Mechanical Engineer

You are responsible for

* Supporting product verification through development, manufacturing and into continuation providing technical support and leadership on a cross-functional team

* Define, document, and continuously improve verification tests including conducting peer reviews and maintaining traceability to requirements

* Perform verification tests and conduct analysis of the test results to ensure complete verification of the requirements

* Identifying, analyzing, owning and driving technical issues to resolution

* Participate in reviews of requirements, design documents, and test related artifacts

* Mentor, coach, and provide work direction to other engineers, technicians and interns

* Proactively own and drive process improvements

* Perform work with little to no supervision

* Participate in CAPA Process like investigation and implementation

To succeed in this role, you should have the following skills and experience

* Minimum 10 years' industry experience in product development environment required with a Bachelors in Electrical or Mechanical Engineering (we pick EE for HW V&V – EE and ME for HW V&V – ME)

* Minimum 8 years' industry experience in product development environment required with a Masters in Electrical or Mechanical Engineering

* Experience desired in a medical device or other regulated industry

* Statistical Analysis experience if preferred

* Working with Standards like 13485, 14971, 62304 is preferred

* Excellent written and verbal communication skills required

* Proven ability to perform problem solving and troubleshooting required

* Strong attention to detail required

* Proficiency in using typical lab equipment (e.g. oscilloscopes, signal generators, spectrum analyzers, voltmeters, etc.) required

* Must be self-motivated and able to work in a fast paced, team-oriented environment

* Ability to work with minimal guidance to make decisions and report progress required

* Demonstrated leadership role in test and issue ownership including ability to provide guidance and direction to less experienced technical personnel required

* Experience with requirements management, configuration management, issue tracking tools, etc. required

* Must be self-motivated and able to work in a fast-paced environment

* Experience with CAPAs highly desirable