Senior Mechanical Systems Engineer

We are looking for a mechanical engineer with a strong background in electro-mechanical system architecture, design, and build. The primary focus of the role is to successfully lead the system mechanical design of ultrasound machines in close collaboration with the Company's system architect from design concept to FDA submission.

As a Senior Mechanical Systems Engineer, your responsibilities are:

• Lead the mechanical engineering development for ultrasound system design within the Design Control process.
• Lead engineering interface to industrial design firms and product management for implementation of the Company's vision for next generation ultrasound systems.
• Develop system requirements for mechanical engineering for eJicient and successful execution by the Company's contract manufacturing partners
• Ensure the system development meets all applicable FDA standards and be a strong partner to the quality team for successful risk management process execution.
• Drive mechanical system development through the Company contract manufacturers, work closely with the management team on program goals and objectives, and be a proactive player in solving challenging design and development issues when they arise.
• Lead engineering teams in the first article prototype builds coordinating the intersection of subsystems from a multi-disciplinary engineering system.
• Ensure the contract manufacturing partners meet the best practices of manufacturing for Company volume and price targets.
• Coach and mentor team members in mechanical systems design. Required Qualifications:
• MS in mechanical engineering
• 10 years industry experience in electro-mechanical design and development
• Experience in Design Control for regulated products and knowledge of applicable regulations (e.g. ISO13485, IEC 60601-1, ISO 14971)
• Experience with relevant manufacturing processes in electro-mechanical systems
• Demonstrated experience in requirements generation and traceability for medical devices
• Demonstrated capability with risk management and failure analysis experience
• Passion for medical devices, with excellent communication and teamwork skills
• Willing to relocate to the St. Louis, MO or Santa Clara, CA areas
• Willing to travel up to 10%

Preferred Qualifications:

• PhD in mechanical engineering
• Experience leading hazard analyses and DFMEAs for electro-mechanical systems
• Experience working directly with an industrial engineering firm for imaging systems in the healthcare industry
• Experience with ultrasound systems or prior experience with industrial design for an electro-mechanical system
• Demonstrated experience designing systems for maximum electromagnetic performance in susceptibility, radiation, and low noise data acquisition capability

Other Qualities We Are Looking For

• Positive - a can-do attitude that helps you rise to challenges
• Collaborative - a team player who can eJectively communicate with others
• Attentive to detail - nothing gets by you
• EJicient - a knack for eJectively prioritizing tasks and managing your time
• Pride in your work - real desire to do quality work
• Career-minded - looking for more than a job
• Empathy - a mindset of producing quality products that help people

Benefits and Perks

We offer great benefits and perks:

• Competitive salary
• Stock options
• Medical, dental, and vision insurance
• 401(k) retirement plan