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Principal HW Engineer - R&D Systems

Bothell, WA 98011

Posted: 01/18/2019 Employment Type: Direct Hire Industry: Software Job Number: 19324

Position Title: Principal HW Engineer - R&D Systems

Position Description: Our client in Bothell, WA  is hiring an Engineer with an EE background (ideally), experience in Medical Device or Aerospace - a Regulated Industry, and demonstrated experience in the product development lifecycle from prototype to verification to release stage.

Job Requirements: 
  • Formulate and manage system functional requirement specifications, risk management and risk assessments.
  • Establish and maintain product requirements trace management via DOORS NG database tool.
  • Ensure traceability of verification tests to product functional requirements.
  • Participate in defect issue tracking and resolution.
  • Work closely with other departments to ensure projects conform to all regulatory and quality regulations.
  • Organize, plan, lead and manage system engineering activities in alignment with project goals.
  • Provide technical leadership in applicable test methods of the products.
  • Identify test cases and write verification test protocols for software and hardware and usability verification/validation that utilize manual and automated test methods.
  • Stay up-to-date and follow all procedures related to this job that can affect the quality of products or services provided to our customers.

Job Qualifications:
  • BS or MS in Engineering plus 5 years of experience designing / validating / testing of complex electro-mechanical systems, and ideally  five  years in medical devices or closely related field.
  • Knowledge / experience in System Engineering concepts/principles and proven track record of successful leadership with system engineering projects
  • Experience with preclinical and clinical studies and evaluations
  • Working knowledge of project planning and management, including use of scheduling software such as MS Project.
  • Demonstrated experience on the use of a requirements management tool (e.g. DOORS/DOORS NG) for requirements management
  • Ability to focus on and achieve scheduled milestones, including contingency planning.
  • Use of defect tracking tools such as TestTrack, JIRA, etc. Knowledge of FDA Quality System and Design Control requirements and their application to projects from design inception to manufacturing release.
  • Regulatory experience in QSR, ISO13485: 2003.
  • Risk Management techniques and experience in EN 14971, EN IEC 60601-1/-2, EN IEC 62304: Medical Device Directive Essential Requirements.
  • Experience in Usability Engineering compliant to EN IEC 62366
  • Experience producing designs compliant to EN IEC 60601-1/-2
  • Working experience with ESD environment.
  • Strong team collaboration and communication skills.
  • Driven to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
  • Demonstrated ability to multi-task.
  • The applicant must be a hands-on self-starter, who has the ability to work collaboratively with a multi-disciplinary product development team in accordance with the standards IEC 62304, IEC 62366, IEC 60601, and ISO 13485.

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

Drew McMillan

In my 3 years of recruiting, I have found that honesty and transparency build lasting business relationships. I work tirelessly to find exciting projects for talented engineers, and will help you achieve your career goals by listening to you and understanding the market. Prior to joining Protingent, I served as a teacher in the Peace Corps in Bulgaria. I love to travel, especially to Europe, and I love my fiancee, my dog and UW Football.

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