The employees at Hemanext are committed to continuing the effort of the transfusion medicine community to save lives and improve patient outcomes. Our distinctive focus is on innovations systems enabling blood collection, processing, storage and transfusion that will promote radical improvement in the quality, safety, efficacy and cost of transfusion therapies.
The role of Senior Product Development Engineer has responsibility for user specifications, design, and materials verification of medical devices for the purpose of blood preservation. As part of the product development team, participate in voice of the customer, specifications, design and development planning and execution, and verification and validation activities. Be a key member of the continuous improvement team for process development as the company continues to grow and regulatory compliance continues to evolve as a result of evolving requirements.
Key Areas of Responsibility:
- Responsible for the specification, product design and development planning, testing and qualification of components, subassemblies and systems for anaerobic blood storage and preservation medical devices.
- Support cross-functional project teams in the development and life cycle of Hemanext blood transfusion products.
- Lead and be a significant contributor in efforts to translate product requirements into manufacturable cost-effective designs, determine and implement product improvements and complete verification activities per design controls for the first-generation device and subsequent generations.
- Support the technical aspects of new product commercialization by effectively utilizing technical knowledge and first-generation learnings to inform the efficient design and development of subsequent product generations.
- Develop characterization and test methods for selection, verification and validation of components, sub-systems and systems.
Education and Experience Requirements
- Bachelors of Science Degree in Mechanical Engineering, Plastics/Chemical Engineering, or related discipline
- 5-12 years’ experience in research and development or design of medical devices.
- Experience in designing, developing, and gaining FDA clearance and CE Mark approval for medical device products.
- Experience in Blood Transfusion, Collection and Separation Technologies a plus.
- Expertise in plastic, disposable medical device design, fabrication, and assembly.
- Strong skills in design of experiments, data analysis, DFM, GD&T, Design for 6 Sigma techniques, written and verbal communications, leadership, and collaboration.
- Extensive knowledge in analyzing and solving problems in a disciplined fashion, ensuring clear understanding of the root cause(s) and efficient recommendations for resolution.
- Proficient in SolidWorks, Visio, Minitab, and Microsoft Office Suite including Excel, Word, PowerPoint and Outlook.
- Must be self-motivated and able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced, entrepreneurial environment.
What Hemanext offers you…
You must be able to provide proof of authorization to work in the United States as a condition of employment.
Hemanext is a smoke-free, alcohol-free and drug-free work environment.
Hemanext is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Hemanext will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
To Apply → Please send your resume to email@example.com or apply through Linkedin.com.