Job Description

InnoTECH Staffing is proud to partner with a cutting-edge medical device company in the Manchester, NH area.

We are seeking a Senior Systems Validation Engineer to join their dynamic R&D team. This is a pivotal role where your expertise will directly impact the success of life-changing technologies.

What Youll Do:
In this high-visibility position, youll play a critical role in ensuring the performance, durability, and reliability of advanced electro-mechanical medical devices. Your contributions will include:

• Designing and executing test plans, test procedures , and comprehensive performance assessments.
• Collaborating with design teams to understand core technologies and develop innovative test methods .
• Determining test coverage for design updates and revisions.
• Creating and evaluating test fixtures to support design verification.
• Investigating design failures and contributing to Risk Assessment, Hazard Analysis, and Fault Tree Analysis (FTA) processes.
• Supporting regulatory submissions by contributing to documentation and quality assurance.
• Drafting Quality Plans, Test Summaries, and technical documentation for internal and external stakeholders.

What Youll Bring:

• A Bachelors degree in Physics, Electrical, Mechanical, or Biomedical Engineering.
• 5+ years of experience testing electro-mechanical medical devices.
• Proven leadership or mentoring experience .
• Strong grasp of engineering fundamentals and problem-solving techniques.
• Exceptional ability to communicate objectives, write procedures , and collaborate with interdisciplinary teams.
• A self-starter mindset with excellent organizational and self-prioritization skills .

Preferred Expertise:

• Knowledge of FDA Quality System Regulations (QSRs) , ISO 13485 , or similar regulatory standards.
• Hands-on experience in product development, testing, and data analysis .
• Broad understanding of measurement instruments and failure analysis techniques.
• Expertise in crafting clear, actionable procedures.

Why Join This Team?
This role offers the chance to shape the future of groundbreaking medical technologies in a collaborative, innovative environment. If youre passionate about advancing healthcare solutions and thrive in a dynamic setting, this is your opportunity to make a difference.

Apply now to become part of a team where your skills and ideas will drive meaningful impact!

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