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 Principal Engineer has responsibilities to drive the planning and completion of assigned engineering projects; including device design and development, manufacturing tooling & fixture design and documentation in order to drive continuous improvement to meet customer needs. This individual will be a key member of the product development team as the company continues to grow and pursue design improvements for next generation products. This is a hybrid position offering a 4 days on-site /1 day remote work schedule.
Key Areas of Responsibility:
- Lead cross-functional project teams in the development and life cycle management of Hemanext blood transfusion products.
- Be significant contributor in technical strategy, tactical implementation and development of IP aligned with business goals.
- Develop product development plans and activities to account for and reduce potential technical and business risk.
- Lead multiple product development efforts simultaneously for major/complex subsystems requiring multi-discipline considerations and ensuring development efforts are aligned to meet product development objectives.
- Mentor junior engineers to solve technical challenges related to product development activities.
- Estimate time and resources required for development activities, anticipate and resolve potential risk, monitor progress and provide updates to project manager.
- Using knowledge of customer needs, develop novel solution to meet product requirements including manufacturability, reliability and cost effectiveness.
- Identify and manage external vendor relationships, including technical development processes and consulting resources.
- Develop test methods and plan verification/validation activities to support regulatory submissions.
- Support manufacturing improvement projects aligned with business goals by identifying opportunities, assessing impact to product performance and execution of required verification and validation testing.
- Coordinate/lead technical and design reviews with cross functional team members to evaluate designs, technical solutions, and completeness of verification activities
Education and Experience Requirements
- Bachelors of Science Degree in Mechanical Engineering, Plastics/Chemical Engineering or related discipline.
- 10-15 years experience in research and development and 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.
- Experience developing solutions for sterile disposable medical devices using biocompatible materials.
- 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…
Hemanext is a pre-commercial company founded on a decade of scientific research and innovation and dedicated to bringing advancements in the world of transfusion therapy, and by doing so, dramatically impacting the patient’s quality of life. We want to create what has never been done before for some of our sickest patients.
You will be working alongside some of the brightest, most creative and patient-focused people you will have ever worked with. We are looking for employees who have a passion and hunger to use their educational and professional experiences to achieve our mission. The stakes are high, and we are working a green field of opportunity to bring about seismic change.
If this appeals to you, we also offer comprehensive Health-care benefits including Medical, Dental and Vision insurance, Stock options, an on-site Gym in Lexington, a 401K retirement plan, Life and disability insurance and 3 weeks’ vacation to start, your birthday off and a week of shutdown at the holidays.
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