Principal HW Engineer - R&D Systems
11720 North Creek Parkway N new 7/22/15 Bothell, WA 98011
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.
- 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.
- 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.