Mechanical Engineer page is loaded## Mechanical Engineerremote type: Office Basedlocations: AUS Stime type: Full timeposted on: Posted Todayjob requisition id: R-25967Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.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 regulated medical devices or combination products is preferred#LS-OS1**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 .The base pay range for this position is:$104,930 - $144,276Factors 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.**EEO is the Law:** Applicants and employees are protected under Federal law from discrimination. To learn more, click .**Reasonable Accommodations:** Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form. If you're#J-18808-Ljbffr