Principal Systems Engineer (Medical Device)

This Jobot Job is hosted by: Emily OlingerAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $130,000 - $170,000 per year

• Full Medical, Vision, and Dental (PPO and HMO)
• Bonus program
• 401k matching
• FSA, Pet Insurance, Life Insurance, AD&D Insurance
• PTO and all major holidays
• 529 College Savings Plan
• Discounts at partnered retailers (gym, phones, etc.)

• Create innovative solutions to address user needs in products that differentiate the company in the market.
• Translate customer needs into requirements and engineering specifications. Document design input & output.
• Meld technical contributors into a unified team and collaborate to determine the best technologies for the product.
• 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 related to the company's products.
• Perform complaint, failure, and risk management activities, develop mitigation and risk control strategies and generate supporting documentation.
• Perform engineering, integration, verification, and validation testing, including protocol development, report generation, and regression analysis.
• Develop and document processes, methods, and tools for product testing and evaluation.
• Support cross-functional Design Transfer process to ensure product designs manufacturable & serviceable.
• Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis.
• Understand, follow and support our 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).

• Experience in the medical device industry.
• Ability to comprehend an extensive variety of technical instructions in mathematical and/or diagrammatic form and translate that into design requirement and/or performance.
• Solid understanding of systems engineering principles and methods, system modeling and transformation applications.
• Familiarity with Engineering Applications like MatLab, LabView or EA.