The job details are as follows: What We Do We 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. With over 100,000 patients on the organ transplant waitlist and only a fraction receiving the lifesaving organ they require, there is a great need for additional sources of transplantable organs. At Miromatrix, a leader in regenerative medicine and a subsidiary of United Therapeutics Corporation, we are working to address this unmet need by bioengineering human organs to help save and improve patients’ lives. Join our team as we continue to make history by developing life-saving therapies to help patients with liver and kidney disease. How you’ll contribute The Senior Engineer, Device Development is responsible for applying technical and subject matter expertise to the research and development of medical device products and components used in combination products. This role involves identifying and solving problems, leading product design and development projects, and supporting the R&D team in developing advanced organ therapeutics. This individual must be an innovative, adaptive, and self-motivated engineer eager to work cross functionally to define the proposed design, generate appropriate design control documentation, conduct verification and validation testing, and complete risk management activities. Develop preliminary device component designs that integrate seamlessly with biologic components of combination products Produce design prototypes and conduct feasibility performance evaluations to inform design selection and design freeze Determine the appropriate design control and risk management deliverables based on relevant regulations, industry standards, and the project scope Develop and document design input requirements and user needs Define and create design output documentation including specifications and labeling Develop and execute verification and validation testing strategies Write testing protocols and reports in support of design verification and validation Conduct verification and validation testing activities and maintain appropriate testing documentation Conduct and document risk analysis activities such as PHA, dFMEA, and uFMEA as required by the risk management plan Communicate relevant information regarding project status, design details, and deliverable content to peer collaborators and executive stakeholders Collaborate with Quality, Regulatory, and other stakeholders on reviewing and approval completed documentation Provide leadership for creation, organization, and management of the Design History File Support the ongoing and evolving technical needs of the Downstream R&D teams including work that may involve cells, tissues, and other biologic source materials Document and support intellectual property development Provide technical input and guidance in defining project priorities and timelines and crafting department goals All other duties as required For this role you will need Minimum Requirements Bachelor’s Degree in material sciences, chemical, biomedical, mechanical engineering with 5 years of experience, or a master’s degree (preferred) in material sciences, chemical, biomedical, mechanical engineering with 3 years of relevant experience, or a PhD in material sciences, chemical, biomedical, mechanical engineering with 1 years of relevant experience 3 years of experience performing ISO 13485 compliant design control activities 3 years of experience performing ISO 14971 compliant risk management activities Experience in prototype design and construction Ability to work independently and as part of a team Ability to use mathematics to solve problems Ability to organize, analyze, and present complex data Work effectively with a cross-functional team to make project decisions Excellent written and oral communication skills Preferred Qualifications Proficient in statistical analysis Proficiency with 3D modeling software (SolidWorks, OnShape, Fusion 360, Creo, etc.) Proficiency in 3D printing and other rapid prototyping methodologies Experience with combination products that include device and biologic components At 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 We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.