R&D Engineer, Med Device, Catheter & Cable Development
Posted on :
07-10-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1675783
Responsibilities:
- Our client is a privately held medical device company based in Northern California growing rapidly in the development of disease modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.
- Reporting to the Director of R&D, this R&D Engineer will work hands on to design, develop and commercialize the next generation catheter while working on the sustaining initiatives on their current line of products. They will also provide technical support to quality and operations on existing commercialized product. The right person will have hands-on design and development experience with the desire to make an impact on patient outcomes in a fast-paced environment.
- Collaborate with the R&D team in the design and development of next generation catheter used with the generator for the management of pulmonary and cardiac diseases.
- Management and development of catheter related risk management file deliverables.
- Work with contract manufacturer to identify and implement design / process build improvements for both the existing commercialized catheter and the next generation catheter.
- Providing technical support to Operations in developing and executing acceptance test protocols.
- Perform and clearly document comprehensive analysis and root cause determination of any product failures associated with complaints.
- Work closely with Quality to identify any trending product failures and follow through with leading CAPA process to address any systemic issues. Provide sound technical solutions pertaining to any process and design updates.
- Provide Regulatory team with technical input and concise documentation in support of regulatory submissions.
- Bachelor's in Mechanical or Biomedical Engineering or equivalent experience
- Medical Device experience
- New product development and design experience
- Ability to adapt quickly in a fast-paced, evolving company and operate with a high sense of urgency
- Working proficiency with MS Word, Excel, PowerPoint, and associated tools
- High Voltage Experience
- Startup experience
- Experience with Electrical. Safety Standards- 60601, 60601-2
- Experience with Electrical Surgical Equipment
- Catheter ablation or rf generator experience
Employment Type
Full Time
Key Skills
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