R&D Project Manager

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Varian Medical Sysetms, a Siemens Healthineers company is seeking an R&D Project Manager 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 managing projects to develop new intravascular therapy 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.

What You will do:

• Support development and feasibility of new and existing intravascular devices and administration kits

• Identify and manage project topics and work with external design companies, consultants, and experts

• Liaise with multiple teams, stakeholders both internal (manufacturing, quality assurance, regulatory, product management) and external (clinical leadership and labs), as well as other project managers within the organization to aid the progression of projects in a timely and high-quality manner

• Support R&D operations

• Ensure that project blockers are identified, remedied and learnings are distilled and implemented in order to prevent re-occurrence

• Develop and champion project progress-tracking and reporting tools

• Create transparency and driving cross team communication

• Plan and prioritize project activities, develop a project schedule and execute project to meet the agreed upon schedule and budget constraints

• Provide written and verbal project updates with manager, project sponsors and other stakeholders regarding project status, risks/issues and accomplishments

• Identify opportunities to improve the product development process and proactively lead change as directed by manager

• Assist in new product development projects and cost-reduction design activities

• Find and work with vendors capable of sourcing both off-the-shelf and custom chemical components

• 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 requirements, process descriptions, and test methods

• Create and maintain FDA compliant Design History Files (DHF)

• Execute process improvements as they relate to quality system compliance with FDA 510(k), QSR and ISO13485

• 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:

• Bachelor’s degree; quantitative or life-science focused is preferred, advanced degree strongly preferred

• 5+ years of working experience in project/program management required, healthcare or academic setting preferred

• Training and experience in project management methodologies (e.g., PMP, SCRUM, Agile)

• Experience using project management tracking systems (such as JIRA, MS Project, etc.) is required

• Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry

• Experience working within a company’s Quality System is preferred

• Experience with design verification & validation

• Professional working experience with Excel and PowerPoint required

• Excellent organizational skills and attention to detail

• Strong communication skills, both oral and written

• A combination of education and experience may be substituted for requirements, we are willing to review candidates with strong and competitive backgrounds that have a passion for science and technology

What will set You apart:

• 2+ years of cross functional project/program management preferred

• Experience in the development of regulated medical devices or combination products is preferred

• Experience in medical device development or healthcare focused project management is