R&D Program Manager - Medical Diagnostics
R&D Program Manager – Medical Diagnostics
An exciting medical diagnostics start-up seeks an R&D Program Manager to lead a product development team developing a new point of care diagnostic platform. The R&D Program Manager should have concept through launch product development experience in medical diagnostics.
· Bachelor's degree in Biology, Biochemistry, Bio-engineering, or other relevant disciplines. An advanced degree is preferred.
· 5+ years experience in medical device / medical diagnostics R&D
· Strong communications skills; oral, written and electronic
· Extremely self-motivated showing great professional initiative
· Strong working knowledge of medical device standards, ISO 13485, MDD, FDA regulated devices; EUA experience a plus
· Project management experience; PMP certification and MS Project a plus
· A track record of accomplishment in developing and mentoring R&D teams.
· Excellent analytical and organizational skills
· Ability to respond to changing priorities and to multi-task, in a dynamic environment
· Lead an R&D team of engineers, scientists, external partners and consultants responsible for research, product design and development.
· Lead teams in solving significant technical challenges; employ structured problem-solving.
· Develop project schedules and budgets to support programs.
· Manage the product development process including the translation of user needs into product requirements, identification of all product design features or performance requirements for which a design path is not readily clear
· Develop and manage V&V requirements and risk management activities
· Ensure product development processes and activities meet appropriate safety and quality standards
· Manage budgetary objectives and make adjustments to project constraints based on financial analysis and strategy
· Foster a culture of excellence by providing ongoing leadership, mentoring, and coaching to all direct reports.
This Job Is:
• A job for which military experienced candidates are encouraged to apply
• A job for which all ages, including older job seekers, are encouraged to apply
• A job for which people with disabilities are encouraged to apply
• Waiting period may apply
• At first, may transition later
• Remote interview process
• Personal protective equipment provided or required
• Social distancing guidelines in place
• Virtual meetings
• Sanitizing, disinfecting, or cleaning procedures in place
Blink Science maintains a work environment free from discrimination, where employees are treated with dignity and respect. All Blink Science employees share in the responsibility for fulfilling our commitment to equal employment opportunity. Blink Science does not discriminate against any employee or applicant on the basis of age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. Blink Science adheres to these principles in all aspects of employment, including recruitment, hiring, training, compensation, promotion, benefits, social and recreational programs, and discipline. In addition, Blink Science's policy is to provide reasonable accommodation to qualified employees who have protected disabilities to the extent required by applicable laws, regulations and ordinances where a particular employee works. Upon request we will provide you with more information about such accommodations.
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Company DescriptionCoupled with vaccines for Covid-19, the world needs low-cost Saturation Level Testing that can be performed by anyone, anywhere, at any time. Instant testing is the key element to end this pandemic, and quickly assess and control the spread of many infectious diseases around the world.
Through licensing and collaboration with several Universities, Blink Science, Inc. is developing an electrochemical method for use with a hand-held device to instantly read a variety of customized disposable strips to detect extremely low concentrations of molecules (viruses, proteins, etc.) in saliva, blood, urine, and other fluids.
This new testing technology will be ultra-low-cost with comparable results to PCR tests overcoming lab-based limitations with portability for global use. We plan to ramp manufacturing rapidly for high-volume device manufacturing and produce more than 10 million strips per day using existing glucose strip manufacturing lines to support a broad set of diagnostics for global distribution.
Blink Science is expanding its core technology through patent coverage and developing a comprehensive digital health platform that includes mobile apps for results verification, personal digital health passport, data transfer with real-time cloud aggregation, third party interoperability, and next-generation IP of using MEMS “Smart chip in testing strips” for multi-functional testing. The company has several notable Fortune 500 collaborations at the present time and growing.
Blink Science is seeking experienced leadership to move this device through an FDA EUA, 510K, and into the global market with consideration for an IPO in the near future. This technology and platform has potential not only for COVID-19 but well into the future for a broad range of 50+ other health and environmental testing applications and available for third-party licensing.