We realize that our success as a company depends on the experience, talents and hard work of our team members.
- Our mission is to develop and enhance therapies to treat cardiovascular diseases. Our number one priority is patient safety.
- We care deeply, work fearlessly, and change lives. We take the responsibility of the trust physicians and their patients place in us seriously and it is something that we earn each and every day.
- We work with a sense of urgency in a competitive world with limited resources at our disposal. We understand that time is money. We plan and iterate our plans continuously to enhance our efficiency and focus. We encourage brainstorming, but execution of plans are rewarded.
- We are data driven and challenge assumptions. We address the elephants in the room. We admit our mistakes and share lessons learned. We preserve the right to change our mind. We are persistently curious and humbled by what there is left to learn. We communicate with passion and clarity.
- We seek to contribute to and own technological advances, product designs, and the relationships with our customers writ broadly.
- We expect and strive to inspire the best in everyone in mind, body, and soul. We value our relationships and are positive, respectful, and open minded. We recognize the importance of family. We provide service and support to our communities as an organization and as individuals.
- We celebrate our accomplishments regularly and aim to have fun every day!
BioCardia is currently seeking a Sr. R&D Engineer.
Position Title: Senior R&D Engineer
FLSA Status: Professional; Exempt
Reports to: VP of Development, Sr VP of Devices
Supervises (job title/s, not name/s): May supervises technicians as required
PURPOSE OF JOB:
Use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company's strategic plan.
MAJOR DUTIES AND RESPONSIBILITIES:
- Apply broad engineering knowledge to the design, development, and planning of new products as well as product changes and enhancements which are consistent with a zero-defect level as well as low product cost.
- Manage design development process steps including obtaining and documenting input from multiple departments in Company to review design aspects for thoroughness and compliance with Quality Systems and Company procedures.
- Ensuring design will undergo final output approval and verification before releasing concept for production.
- Solve multidisciplinary engineering problems at the component through system level.
- Develop test protocols and conduct testing utilizing test protocols as needed.
- Interpret and analyze test results, generate written reports.
- Assign work to technicians and temporary workers as needed.
- Complete projects (including product enhancements) in a manner consistent with corporate objectives.
- Contribute to the intellectual property position of the company via invention, development of proprietary processes, and patent applications.
- Maintain accurate documentation of concepts, designs, drawings, and processes and ensure appropriate documents undergo the appropriate design review functions.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- Provide multidisciplinary engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
- Resource, identify and oversee outside vendors and consultants as required.
- Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post-production QSR compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
- Provide multidisciplinary engineering support in the resolution of product complaints and/or safety issues.
- Work with other engineering, manufacturing, clinical affairs, sales and marketing, and quality assurance staff to coordinate pilot production of new products.
- Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
- Develop, analyze, evaluate, and modify specific design features and tolerances.
- Create solid models and Engineering drawings documenting product designs and product test and assembly fixturing.
Education and/or Job Experience:
- Four year college degree in mechanical, biomedical, or other engineering discipline or related scientific or biomedical field, trade school degree or equivalent; or related work experience.
- Ability to communicate in English sufficiently well to support R&D responsibilities.
Special Skills, Abilities, and Requirements:
- Hands on ability to evaluate, troubleshoot, and solve catheter design and assembly and other engineering problems
- Experience with Medical device product development, equipment or mechanical design
- Ability and skilled in the use of 3D modeling software, such as SolidWorks, Pro Engineer, or other related Mechanical Design Software
Nice to Haves / Areas for Growth:
- Hands on Prototyping, Machining and Assembly skills Such as 3D printing or part machining.
- Excellent communication skills.
- Finite Element Analysis software
- High energy, self-motivated.
- Experience and understanding intellectual property creation and development.
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