Mechanical Engineer

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Varian Medical Systems, a Siemens Healthineers company is looking for a Mechanical Engineer to join our Interventional Oncology (IO) development team. The individual will be a member of our growing embolics team that is focused on treating cancers by delivery internal chemical/radiation therapy and occluding the blood supply to tumors. The individual would contribute by developing new intravascular therapy products and mechanical devices for administering intravascular therapy. The ideal candidate would be a self-driven individual with a passion for medical device development and a desire to work on products that change people’s lives.

What You will do:

• Develop prototype intravascular devices and administration devices for delivering intravascular therapies to demonstrate technical feasibility
• Define detailed requirements for administration and implantable devices
• Support design and development of microsphere formulations towards mechanical properties, material properties, and deliverability
• Manage relationships with external consultants for administration device design, component sourcing, and production
• Design new parts, assemblies, and subsystems for intravascular therapy devices
• Develop effective solutions by application of concepts, techniques, knowledge, and processes to the problems within the field of mechanical engineering
• Develop and execute complex test plans involving significant data collection and interpretation, assessment of results, and incorporation of step for continuous design improvements
• Contribute to formal design and instrumentation drawings, analysis plans, and fabrication plans
• Design and improve benchtop vascular flow models for evaluation of administration devices and intravascular therapies
• Support development and prototype building of shielded transport containers
• Hands-on mechanical design, detailing, documentation, and functional validation of mechanical components and related sub-assemblies or systems
• Create drawings and layouts of new or improved designs in SolidWorks for prototype and manufacturing capable fabrication
• Plan and conduct R&D activities to define and develop implantable devices
• Quality assurance testing of devices to ensure conformance to design specifications
• Write technical documentation including process descriptions and test methods
• Contribute to and maintain FDA compliant Design History Files (DHF)
• Execute process improvements as they relate to quality system compliance with FDA 510(k), QSR and ISO 13485
• Participate in complaint investigations, and failure analysis of products
• Provide root cause analysis support and drive the implementation of corrective action for process-related issues
• Perform other duties as assigned or required

What You will have:

• BS in Mechanical Engineering, Materials Engineering, or related field; MS preferred
• 5+ years of engineering experience with preference to experience in medical device or other regulated industry; 7+ year experience preferred
• Experience with mechanical design of flow-directed medical devices, such as catheters, injection devices, and administration kits
• Experience with material and mechanical properties of implantable medical devices
• Experience of engineering design with Solidworks including solid modeling, assembly, drawing, dimensioning, and tolerancing
• Experience working with outside vendors to build customized components
• Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry
• Experience with design and development process for mechanical devices, including defining requirements, prototyping, usability, and design verification & validation
• Able to define and develop test procedures and to perform design verification

What will set You apart:

• Experience with radiation shielding, transport container design, and packaging engineering is preferred
• Experience with design of anatomical flow models for intravascular medical device assessment is preferred
• Knowledge of biocompatibility ISO-10993 requirements for medical devices is preferred
• Experience working within a company’s Quality System is preferred
• Experience in the development of <