Overview
InnoTECH Staffing is seeking a Senior Systems Validation Engineer to work in a dynamic medical device R&D environment for a company in the Southern, NH area. This is a high visibility role with a direct impact on the success of our projects. It will be a great opportunity to work on some amazing projects that make a positive impact on the world.
This requires being onsite 5 days a week. There is no sponsorship at this time.
How you will make an impact
* Writing test plans, test procedures and other activities involving performance, durability, and reliability assessments
* Understand device design and core technologies in order to inform test method development
* Determining test coverage for revisions to design
* Creating and evaluating test fixtures needed for product design verification
* Contributing to design failure investigations that may impact Risk Assessment, Hazard Analysis, and FTAs
* Participating and contributing toward regulatory and agency submissions
* Authoring Quality Plans, Test Summaries, and other documents
Qualifications / What you need to be successful
* BS in Physics, Electrical, Mechanical and/or Biomedical Engineering
* 3+ years' experience testing electro-mechanical medical devices
* Leadership and/or mentoring experience
* Knowledge and deep understanding of engineering fundamentals
* Capability to create and clearly explain team objectives and write procedures for others to follow
* Demonstrated problem solving ability and techniques
* Ability to work as part of an interdisciplinary team
* Self-motivated and able to self-prioritize
* Must have excellent verbal and written communication skills
Skills and experience
* Knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485, and other medical device industry experience
* Experience with research, development, and product testing
* Experience writing procedures for others to follow
* Experience with data and failure analysis
* Broad measurement instrument knowledge
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