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Lead Medical Device Engineer, Sterilization

1 month ago

Manchester, United States United Therapeutics Full time

California, US residents click here.The job details are as follows:What We DoWe build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.How you'll contributeThe Lead Medical Device Engineer will develop and implement processes for sterilization of 3D-printed lung scaffolds. This role is responsible for developing robust assays and quality controls to ensure proper reduction in bioburden. Additionally, this position will support other post-printing methods to support timely transfer of scaffolds to Tissue Engineering group. Lead the sterilization of 3D printed scaffoldsPlay a significant role in the development of the contamination control strategy of 3D printed lung scaffoldResponsible for management and performance of routine QC testing such as bioburden, endotoxin, B&F testing, growth promotion, Gram stain, microbial ID analysis and raw materials testingCo-develop different assays to map perfusion in 3D printed scaffoldsPlan, organize, and prioritize own daily work routine and microbiology routine to meet established scheduleAll other duties as requiredFor this role you will need Minimum Requirements6+ years of experience in a product or process development role, preferably with a minimally invasive medical device product company with a Master's Degree in chemical engineering, microbiology, or related field or 3+ years of experience in a product or process development role, preferably with a minimally invasive medical device product company with a PhD in chemical engineering, microbiology, or related field5+ years of experience with solid technical knowledge of Microfluidics, sterilization and aseptic techniquesStrong understanding and experience in handling and sterilization of medical devicesAdvanced competence in Solidworks; strong experience in microfluidics, handling of large quantity of sterilantDeep understanding in sterilization techniques - chemical and radiation methodsExperience in B&F (Bacteriostasis/Fungistasis) testing, growth promotion, Gram stain, microbial ID analysis and raw materials testingExperience with Endotoxin and Bioburden testingPreferred Qualifications1+ years of experience with sterile product design, manufacture and packaging experience and related standardsAt United Therapeutics, you'll realize quickly that it is not an ordinary place to work When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers' credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities