Staff Equipment Engineer
Palo Alto
Operations – Process Control /
Full-time /
On-site
At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.
This is a hands-on position that develops, implements, and maintains equipment (including the methods and processes) for the manufacture of medical devices. Such critical equipment development must comprehend manufacturing cost, determine time standards, and include safety, and process failsafe-ing. This role is expected to make recommendations for tooling and process requirements of new or existing product line equipment. It will provide support to the Operations team to enable the manufacturing line and advance commercial control and readiness activities for Recor manufacturing. It will ensure support of efficient, safe, and high-quality products while maintaining full regulatory compliance. Position reports to the Sr. Manager, Process Control.
This position requires an independent, critical thinker, that is who is a strong team player. This person is comfortable working at a fast pace, with high attention to detail, process, and quality.
Responsibilities and Duties
- Identification and implementation of system improvements for equipment control, including standard operating procedures (SOPs) and individual equipment specifications
- Development and execution of procedures for systematized equipment qualification, including factory acceptance testing (FAT) and site acceptance testing (SAT)
- Equipment development including: Characterization; Drafting/reviewing equipment design requirements & specifications; Safety considerations
- Equipment obsolescence tracking and response
- Implementation of new or revised equipment systems, including protocol and report writing
- Hands-on qualification, maintenance, and troubleshooting of production systems integrating mechanics, electronics, and software
- Support production capacity improvements
- Support equipment investigations and root cause analysis
- Support equipment calibration and preventative maintenance program
- Ability to gather and analyze results to make data driven decisions
- Update and maintain proper Quality System records
- Experience working in a clean environment room (CER)
- Experience with clean dry air (CDA) systems
- Manage multi discipline groups for project execution and implementation
- Plan, prioritize, coordinate, and execute tasks and projects activities with minimal guidance
Requirements
- Bachelor of Science degree in Engineering or related field with a proven track record of equipment development and implementation for volume production
- Minimum 8+ years' experience in a regulated environment such as medical devices with an understanding of domestic and international regulatory standards (i.e. FDA QSR, ISO 13485 and MDD/MDR)
- Working knowledge of design controls, process validation, statistics, and design of experiments
- Proven record of product engineering leadership resulting in quantifiable improvements in quality, yield, cost or process
- Effective verbal and written communication skills; ability to write clear procedures
- Exhibit good problem solving and analytical skills
- Self-motivated, action oriented and result oriented
$145,000 - $169,000 a year
(Commensurate with experience, skills, education and training)
COVID-19 vaccination requirements
At Recor Medical, we care, we collaborate, we challenge, and we create. Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology. COVID-19 vaccines will be required for all ReCor US office employees effective June 10, 2021, as well as all new US office employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.
Equal Employment Opportunity
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
