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Varian Medical Systems, a Siemens Healthineers company is looking for 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 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 preferred
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Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
To find out more about Siemens Healthineers businesses, please visit our company page here.
The base pay range for this position is:
$104,930 - $144,276
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, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.
Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
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