Sr. R&D Engineer, Ventus Medical, Inc. (Belmont, CA)
SUMMARY:
The engineer in this position will be responsible
for design and development of new products as
well as engineering support of clinical studies
and on-market product. The job will include such tasks as:
• Design and development of respiratory devices.
• Development of test methods, protocols and fixturing.
• Performing testing, analyzing data, and presenting results.
• Execution of the device logistics to support clinical studies.
This key position works with all departments of
the company to integrate design, marketing,
reimbursement, medical, quality, and regulatory aspects of our products.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
• Lead cross-functional team of internal and
external stakeholders to define products, reduce
concepts to practice, and bring new devices to market.
• Interface with all departments to provide
guidance and leadership on the use of R&D
Engineering methodologies, tools, engineering and
design requirements, etc and assist in solving
day-to-day design and engineering issues.
• Provide guidance during product development and manufacturing ramp-up for
both Quality and Supply Chain.
• Ideation of device concepts to meet clinical and market needs.
• Design and prototyping of device concepts,
including creation of CAD models and engineering
drawings and interacting with prototyping vendors.
• Develop test methods, protocols, and fixturing
to support product verification and validation. .
Use basic statistical methods to analyze data and
communicate results, conclusions, and recommendations.
• Development of quality system documentation to
support pilot production and design transfer.
QUALIFICATIONS:
• Minimum of 10 years experience in medical
device industry and small company experience strongly preferred.
• Experienced in delivering products to market,
including development through design controls and
product & process verification and validation.
• Knowledgeable in design of small parts for
injection molding. Experience with fluid
mechanics and designing with elastomers a plus.
• Demonstrates familiarity with medical device
quality systems and the applicable regulations
(GMP, ISO, QSR, Design Controls).
• Basic Solid Works CAD skills, including development of engineering drawings.
• Proven abilities in problem solving,
communication (both written and verbal), and organization of project tasks.
• BS or higher in relevant engineering or scientific field.
To apply, please email:
Art Ferdinand, Director of R&D
art@ventusmedical.com