- Conceptualize and iterate component and assembly designs from brainstorming to concept realization.
- Design and develop proof-of-concept prototypes, disease models, and test methods.
- Utilize rapid prototyping techniques and resources to facilitate design iterations.
- Oversee verification and validation testing and generate related protocols and reports.
- Analyze mechanical systems for risks and opportunities for improvement.
- Collaborate with suppliers for high-quality prototype and assembly development.
- Support the performance of equipment qualifications and process validations.
- Generate and maintain comprehensive component and assembly documentation.
- Coordinate with a cross-functional team to define and accomplish design and development goals.
- BS/MS in Engineering with 2-4+ years' experience in medical device or other highly regulated field.
- Experience with disposable catheter-based medical device design and material selection preferred.
- CAD skills, including generation of component specification drawings – Solidworks preferred.
- Strong problem solving and critical thinking skills.
- Effective communicator with the ability to explain technical concepts to a variety of audiences.
- Keen attention to detail (see the trees), with awareness and attention to high-level design goals and company direction (see the forest).
- Effective multitasking and organizational skills.
- Familiarity with FDA regulations and common regulatory strategies is a plus; 510(k), De Novo, EFS, Pivotal Trials
- Experience collaborating with clinical and regulatory teams
- Knowledge and application of quality principles and risk management practices
- Health, Dental, Vision, and Life Insurance (via TriNet)
- Flexible PTO
- Hybrid work environment
- 401(k)
- Equity vesting currently under development
Research & Development Engineer Medical Device - San Jose, United States - AngioSafe, Inc.
Description
AngioSafe is a growing Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development. Our seasoned experts are committed to producing high-quality and innovative products to decrease risk and improve outcomes of arterial disease. Our mission is to enable complex coronary and peripheral vascular interventions by all interventionists in all catheter labs.
We have an exciting opportunity for an R&D Engineer. The successful candidate is a hands-on "do-er" who is able to apply their technical intuition and understanding to develop innovative solutions to design challenges.
At AngioSafe we value an inclusive innovative culture. You will join a team that offers great balance, extensive professional opportunities, and a collaborative environment.
Be at the forefront of novel vascular device development Join us and help AngioSafe simplify and improve complex interventional algorithms.
What you can expect in this role
Primary focus:
Your skills and expertise will include:
Salary Range $115,00 - $175,000
Benefits:
Principals only Please