I have just partnered with an established Medical Device company looking to bring on two R&D Test Engineers!
Day to Day:
- Perform engineering, integration, verification and validation testing.
- Take ownership of test protocols for design verification and Life/Reliability tests development, including protocol development, report generation and regression analysis.
- Develop clinically relevant test methods to ensure design requirements are sufficiently verified by collaborating with appropriate cross functional partners.
- Document processes, methods and tools for product testing and evaluation.
- Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, and field issues with technical and impact analysis.
- Proactively engage with appropriate engineering teams on failure investigation and root cause analysis.
- Develop, manage, and maintain design history files and related deliverables.
- Develop, maintain, and execute to plans, milestones, schedules and task lists.
- Manage and logically organize data to identify and describe problems and assess the suitability and quality of technical solutions.
- Maintain up-to-date knowledge of medical devices, technologies and regulatory landscape relate to the company’s products.
- Perform complaint, failure and risk management activities, develop mitigation and risk control strategies and generate supporting documentation.
- Support cross-functional Design Transfer process to ensure product designs are manufacturable & serviceable.
- Understand, follow and support internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
Requirements:
- Bachelor of Science in an engineering discipline (mechanical, electrical, controls, etc.).
- 2-8 years experience in hands-on testing of mechanical and electromechanical systems.
- Medical Device Verification/Validation testing experience.
- Understanding of design controls used in Medical device development.
- Familiar with electro-mechanical test equipment, including sensors, actuators, test automation, and data collection methods.
- Familiar with Design of Experiments techniques, including defining test population sizes and significance of test results.
- Experience using tools and measuring equipment (Force gauge, calipers, Ingstron, Oscilloscopes, Coordinate Measurement Machines)
- Ability to perform mechanical engineering calculations need to support test fixture design, including dimensional analysis
- Strong analytical skills and ability to apply engineering principles using logicalor scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to comprehend an extensive variety of technical instructions in mathematical and/or diagrammatic form and translate that into design requirement and/or performance.
- Ability to find creative or innovative solutions for design of products.
- Understanding of systems engineering principles and methods, system modeling and transformation applications.
- Ability to make and communicate decisions in a timely fashion to formulate and execute a course of action.
- Ability to independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines.
- Ability to adjust to changing timelines and priorities in a fast-paced environment.
- Ability to collaborate cross-functionally and cross-organizationally and respond to the needs of internal customers.
- Strong interpersonal and communication skills and ability to effectively work in a team.
- Excellent written & verbal English communication skills and strong presentation skills.
- Adept use of Office Applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project.
- Familiarity with Engineering Applications like MatLab, LabView or EA.
