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 innovative systems enabling blood collection, processing, storage, and transfusion that will promote radical improvement in the quality, safety, efficacy, and cost of transfusion therapies.
The Senior Product Development Manager role is responsible for providing technical input to establish program objectives, driving technical activities and effectively identifying and providing appropriate engineering resources for Medical Device development from product inception through market introduction. In order to be successful in this role, the individual must be collaborative, self -driven, adaptable, result-oriented, and able to deliver results in a high performance, high intensity, early stage company. This is a highly visible position with exposure to the customer, senior staff and vendors. The position will interact with several departments within the organization.
Key Areas of Responsibility:
- Provides technical input for strategic roadmap for developing and refining product portfolio.
- Responsible for the ideation, development and transfer to manufacturing of a product that meets user needs, product requirements, manufacturability and quality levels.
- Technical lead for Phase Reviews and ensures that development is progressing according to quality objectives and project goals.
- Schedules and runs effective technical meetings to keep technical staff aligned, address issues, identify and mitigate potential technical risks. Publishes minutes and ensures action items are completed.
- Gathers market data and information on customer groups in collaboration with Marketing, Clinical and Sales to generate new products.
- Develop technical resources, with best-in-business skill sets required for product development including in¬ depth materials, system and troubleshooting knowledge of the product and manufacturing processes. A key responsibility of the Senior Manager role is to establish and maintain an agile resource pool of the above engineers through hiring, development and optimization of a lean internal team as well as proactively establishing strong relationships with external groups who can fill either competency or capacity gaps on short notice.
- Member of Core Team and responsible for delivery of quality products on time and within budget.
- Effectively communicates and tracks status, escalates concerns, issues and works with team to resolve issues and implement resolutions.
- Ensures compliance with Hemanext SOP’s, QMS and other regulatory requirements including creation of design and phase reviews. Provides content to Design History File(s) for the project(s).
- Demonstrates role model core team behaviors.
- 10 – 15 years of related experience in product development of medical devices, including FDA clearance and CE Mark approval.
- 5-10 years of experience in staff or project management of medical products over entire product lifecycle
Specific Industry Experience:
- Experience in Blood Transfusion, Collection and Separation Technologies a plus.
- Experience with sterile disposable medical devices, design V&V, process validations and clinical validation studies is a plus.
Educational Requirements and Skills Requirements:
- Bachelor’s’ degree in Materials, Mechanical, Biomedical or related Engineering, advanced degree is a plus.
- Demonstrated execution at meeting project goals while satisfying quality, performance, schedule and budget requirements.
- Exceptional interpersonal and leadership skills to effectively communicate and build relationships at all organizational levels.
- Exceptional technical aptitude, knowledge of multiple disciplines and technologies to effectively interface with diverse technical team and drive technical solutions and deliver effective medical products.
- Familiarity with ISO, FDA and other regulatory standards.
- Proficient in SolidWorks, Minitab or equivalent application, Microsoft Office Suite including Excel, Word, PowerPoint and Outlook, MS Project.
What Hemanext offers you…
Hemanext is a pre-revenue 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, 401K retirement plan, Life and disability insurance and 3 weeks’ vacation to start.
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.