Product Development Scientist - Remote
Austin, TXFrom $104,930/yr
Join 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 seeking a Product Development Scientist 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 providing scientific expertise in their field to support product, process, and test method development of next generation intravascular medical devices. The individual would support preclinical, biological, and non-clinical studies required to characterize products, in addition to other assessments and regulatory submission support. 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 studies to characterize products and processes related to product development of implantable intravascular therapies Design and conduct studies (pre-clinical, in vivo, in vitro, analytical) to assess new products and product applications Coordinate pre-clinical study tasks from study initiation to study completion Manage contracting with third party vendors including the development of timelines and cost estimates for preclinical tasks Develop protocols and final reports associated with pre-clinical work to support regulatory submissions for new designs or product improvements Develop and execute complex test plans involving significant data collection and interpretation, assessment of results, and incorporation of step for continuous design improvements Lead collaborations with toxicologists and pre-clinical experts to develop biocompatibility assessments based on ISO-10993 requirements Collaborate with regulatory affairs teams to write pre-submissions and full submissions for FDA 510(k) and/or PMA medical devices processes Collaborate with product development engineering to perform design verification and validation activities Collaborate with product development engineering to develop and maintain use risk hazard analyses, design failure modes and effects analyses, and other product risk documentation 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 Perform other duties as assigned or required What You will have: BS in Biology, Biomedical Engineering, or related field; MS or PhD preferred 3+ years of scientific or engineering experience with preference to experience in medical device or other regulated industry; 5+ years is preferred Experience in the development and qualification of pre-clinical studies is required; Familiarity with the medical device Regulatory (FDA \& MDD) and Quality (QSR \& ISO 13485) issues or similarly regulated industry Working knowledge of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) Experience with design verification \& validation Able to define and develop test procedures and to perform design verification What will set You apart: Experience working within a company’s Quality System is preferred Experience in FDA pre-submission and submission preparation is preferred Experience in the development of regulated medical devices or combination products is preferred Experience in veterinary surgery is a plus Experience with interventional radiology or brachytherapy-related studies is preferred, including x-ray imaging and pre-clinical animal models Experience with biocompatibility ISO-10993 testing and requirements for implantable devices is preferred Experience in clinical and pre-clinical study workflow for embolic, radioembolic, or brachytherapy procedures is preferred * Knowledge of laboratory techniques such as chemical analysis (XRD, DSC, sizing, FTIR) and mechanical analysis is a plus #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 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. EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here. 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 here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here. Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.” Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
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