Chemical Engineer

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Varian Medical Systems, a Siemens Healthineers company is looking for a Chemical Engineer or Biomedical 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 applications for existing microspheres and maintaining our existing microsphere products.

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.

• Improve and sustain microsphere and polymer manufacturing processes, including optimization, new tool/process development, scale-up, and resource coordination
• Develop new applications for microsphere and polymer-based implantable devices
• Transfer knowledge of synthesis processes to manufacturing for ongoing production
• Development and execution of 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
• Develop biocompatibility assessments based on ISO-10993 requirements
• Define and prepare pre-clinical study plans for new device investigation
• Quality assurance testing of devices to ensure conformance to design specifications
• Find and work with vendors capable of sourcing both off-the-shelf and custom device components
• Write technical documentation including process descriptions, test methods, and technical drawings/drafting
• 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

• BS in Chemical Engineering, Biomedical Engineering, or related field
• 3+ years of engineering experience with preference of experience in medical device or other regulated industry; 5+ years is preferred
• Experience in polymer or microsphere synthesis optimization, development, and scale-up
• Experience in technical drawing/drafting
• Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry
• Experience with design verification & validation
• Able to define and develop test procedures and to perform design verification

• Masters Degree or PhD preferred
• Knowledge of laboratory techniques such as mechanical testing (rheology, compression) and chemical testing (NMR, FTIR) is preferred
• Experience in inorganic polymer synthesis is a plus
• Experience with biocompatibility ISO-10993 testing and requirements for implantable devices is preferred
• Experience with pre-clinical study preparation and interventional radiology device use is preferred
• Experience working within a company’s Quality System is preferred
• Experience in the development of regulated medical devices or combination products is preferred

The base pay range for this position is: $ - $ USD

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position,…