United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.
The job details are as follows:
What We Do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
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, pediatric cancers and other orphan diseases.
In 2021, we became 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.
How you’ll contribute
The Senior Product Development Engineer, Combination Products will provide senior support for combination products / medical devices product development and support the research of new/emerging technologies, verification/validation, design transfer, and documentation associated with medical devices and/or combination products.
- Support combination product development, verification/validation, design transfer and documentation activities
The Lead Product Development Engineer will serve as subject matter expert for combination products / medical devices product development and support the research of new/emerging technologies, verification/validation, design transfer, and documentation associated with medical devices and/or combination products.
- Lead and support combination product development, verification/validation, design transfer and documentation activities
- Identify and manage outside vendors/suppliers/partners/consultants in support of product development activities
- Maintain knowledge of and ensure all activities are compliant with all relevant regulatory standards (e.g., 21 CFR Part 820, ISO 13485)
- Use and apply personal advanced technical expertise and experience, concepts, company policies, and procedures to solve a wide range of difficult problems in imaginative and practical ways
- Provide “hands-on” advanced support of prototyping, reworking, and/or testing of medical devices / combination products
- Author product specifications, test protocols, technical reports, SOPs, CAPA reports, and other quality documents as needed
- Research new/emerging technologies, products, and test methods in support of infusion systems and aerosol delivery
- May participate in the development of patent applications
- May supervise 1-2 direct reports
- All other duties as required
For this role you will need
- Bachelor’s Degree in Arts/Sciences (BA/BS) in Engineering (ME, Biomedical, EE/Systems preferred)
- For the Lead Engineer level: 8+ years of general product development experience with a Bachelor's degree and 6+ years of experience in a regulated industry OR 6+ years of general product development experience with a master's degree
- For the Senior Engineer level: 5+ years of general product development experience with a Bachelor's degree and 3+ years of experience in a regulated industry
- Working knowledge of Design Controls and/or Product Development Process
- Demonstrated knowledge in systems engineering / multi-discipline engineering projects
- Able to work independently with occasional need for guidance
- Knowledge of relevant medical device / combination product industry standards, including but not limited to: ISO 13485, ISO 14976, ISO 10993, IEC 60601-1, IEC 60601-1-2, and IEC 62304
- Proficiency with Microsoft applications (Word, Excel, Project, PowerPoint) for documentation, data analysis, and presentation
- Able to mentor and/or provide technical guidance to other engineers / project team members
- Working knowledge in statistics, data interpretation/presentation, engineering experiments/ design of experiments (DoE)
- Master’s degree (MA/MS/MBA) in Engineering (ME, Biomedical, EE/Systems preferred)
- For the Lead Engineer level : 6+ years of medical device and/or combination product development experience
- For the Lead Engineer level : 3+ years of experience leading multi-discipline engineering projects
- For the Senior Engineer level: 3+ years of general product development experience with a Master's degree
- For the Senior Engineer level: 3+ years of medical device and/or combination product development experience
- For the Senior Engineer level: 3+ years of experience leading multi-discipline engineering projects
- Experience with injection-molding and Design for Manufacturing (DFM) processes
- Experience with biocompatibility, extractables/leachables, and sterility testing/processes
- Experience in process development activities for manufacturing / assembly operations
- Experience with common lab test instrumentation and equipment, design of jigs, fixtures, process equipment, and software
- Experience in human factors engineering
- Experience with computer aided drafting tools such as SolidWorks and Creo
- Experience with analytical software such as Minitab, Matlab or MathCAD
- Electronics aptitude, including the ability to read schematics, wiring diagrams, and soldering skills
- Ability to build prototypes from assembly bill of materials and/or schematics
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.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities