PRINCIPAL R&D ENGINEER | GenomeWeb

PRINCIPAL R&D ENGINEER

Organization
Drawbridge Health Inc
Job Location
2882 SAND HILL RD
STE 240
MENLO PARK, CA 94025
Benefits

Medical, dental, etc

Job Description

Drawbridge Health is seeking an experienced, versitile and hands-on component design and systems integration engineer with a passion for developing and commercializing transformative medical diagnostics and devices. Reporting dirctly to the company's Senior Director of Product Development, the Principle R&D Engineer will lead a multi-faceted design and development effort that integrates proprietary technology developed by GE Research into a paradigm-shifting sample collection and stabilization platform for both the US and global markets. S/he will ensure that all aspects of the product and considered and integrated as a whole. S/he will work closely with internal and external bioscience and engineering experts to develop a product that can be verified and validated successfully as a system meeting the marketing, clinic, quality, regulatory, or other requirements.

 The ideal candidate will have a proven track record of designing and delivering world-class medical device and/or diagnostic products.S/he will couple an entrepreneurial, hands-on approach with best-practice design and development processes learned in previous roles at successful companies to deliver outstanding products on sggressive timelines. The successful candidate will be able to think out-of -the-box and implement effective product development processes and will hve strong organizational skills and the ability to bring a sense of urgency to all high priority activities. S/he will need to also understand user needs and sample collection and diagnostics workflows and processes to fully realize a seamless user experience. S/he will have formal experience working with an internal quality system, design controls, and regulartory experts to bring products through FDA clearence. 

SPECIFIC RESPONSIBILITIES

 Develop and deliver high quality, innovative diagnostics/medical devices, taking conception through manufacturing, testing, regulatory approval and market launch.

Partner with technical leadership and key customer to identify user needs and translate needs into design requirements and technical specifications. Key customers include patients, healthcare providers and clinical diagnostics lab staff.

Oversee design, prototyping and development of device system components to meet customer needs.

Partner with technology and component experts to integrate, evaluate and modify component and system designs to meet overall user requirements.

Identify, develop and validate bench and design verification test method

Collaberate with technical leadership to identify pre-clinical research needs and lead in vivo pre-clinical studies

Partner with regulatory/quality and other team members to prepare regulatory submissions

Collaborate with manufacturing team members or contract manufacturers in transferring design from development to steady-state production

Connect cross-functional team members and partners across product marketing/ user experience, science/engineering, clinical/ regulatory/ quality, and supply chain/ manufacturing to developer product

 

 

Requirements

MINIMUM QUALIFICATIONS
 BA/BS degree in mechanical or biomedical with emphasis in mechanical engineering
 5 years of medical device development experience
 Proven track record of success within medical device/diagnostics R&D organizations
 Experience designing, specifying, testing, and characterizing custom components and integrating
 Ability to quickly come up to speed on medical applications and needs
 Solid engineering and project management skills as well as technical and IP acumen
 Excellent written and oral communication and interpersonal skills

PREFERRED QUALIFICATIONS
 Advanced degree in mechanical engineering, biomechanical engineering or similar
 Familiarity/ experience with one or more of the following areas/technologies: microfluidics, blood draw, transport and diagnostics processing, microneedles, injection molded plastics
 Experience/familiarity with regulatory strategies consistent with 501(k) and/or PMA
 Demonstrated ability to work in a start-up or other fast-paced environment.
 Experience with technology transfer to 3rd-party contract manufacturing partners

PERSONAL CHARACTERISTICS

 Entrepreneurial zeal, high energy and fervent desire to make a large impact on healthcare
 Pro-active, resourceful, collaborative and “hands-on”
 Enjoy the startup environment where pace is fast and uncertainty is commonplace
 Be “data-driven” in all aspects of product design and assessing customer feedback
 Love simple, intuitive, functional design and processes
 Concise, persuasive and disciplined
 High ethical standards, team player, professional integrity, accountability

 

How to Apply
About Our Organization

Drawbridge Health – Making Sampling Simpler

Drawbridge Health is a medical technology company fusing the science of chemistry with the fundamentals of logistics to access and immediately stabilize the blood sampling process, anywhere. Our mission is to power the shift in healthcare from being reactive to proactive, enabling predictive medicine to be realized by bridging diagnostic testing from sample to delivery to decision. This transformation begins with how we approach the collection and interpretation of medical diagnostic tests—the data that we use to make nearly all of our medical decisions. The current sample collection and testing paradigm is not only inconvenient and costly for consumers and medical providers alike, but is incomplete and not tailored to the individual. Drawbridge Health is building a new blood sample acquisition and stabilization platform to enable the broad access, cost-effectiveness, accurate, and actionable information necessary to pave the way for truly individualized and predictive healthcare.

We are building a team that combines the best talent at the intersection of diagnostics, medical devices and consumer product design. Come join our team of biologists, biochemists, technologists, design engineers, product developers, and all around techno-athletes with a passion for working on problems that matter and require ingenuity and grit to succeed. Help make decisions that will shape our technology, product and company culture.

Drawbridge Health is backed by experienced VC’s and partners.

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