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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