Staff Manufacturing Engineer
Palo Alto
Operations – Manufacturing Engineering /
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.
The Staff Manufacturing Engineer is a hands-on position in the operations department which will advance production capacity readiness activities for the 2.5 and 3.1 program. This Position reports to the Senior Catheter Manufacturing Engineering Manager.
Responsibilities and Duties
- Manage multi discipline groups for project execution and implementation.
- Authoring validation, qualification protocols and reports
- Hands on development, qualification and implementation of new production systems integrating mechanics, electronics, and software.
- Identify and drive production capacity improvements.
- Identify, manage, and qualify alternate supply sources or new vendors.
- Hands on investigation and root cause analysis
- Define process corners and product process targeting from characterization results.
- Characterize NPI product performances and yield including bench correlation to meet product cost targets.
- Advises / leads other engineers on complex issue resolution.
- Supports the regulatory submission process in compliance with all ISO, EN MDD and FDA regulations and requirements.
Requirements
- Bachelor of Science degree in Engineering or related field with a proven track record of transitioning products from NPI to volume production.
- Minimum of 8 years of experience with NPI; specifically, in product engineering and assembly with focus on yield, cost and manufacturing process improvements.
- Must have experience in a regulated environment such as medical devices.
- Experience with disposable devices (Class II / III), preferably balloon catheters and sterile packaging.
- Strong collaboration skills with contract manufacturers and suppliers that include aligning goals, managing expectations, and ensuring adherence to specifications and timelines.
- Working knowledge of injection molded plastic components is a plus.
- Experience with complex data analysis using JMP, MiniTab, or other yield tools
- CAD experience preferred (SolidWorks).
- Proven record of product engineering leadership resulting in quantifiable improvements in quality, yield, cost, or process.
- Self-motivated, action oriented and result oriented.
- Deep understanding of medical device processes and assembly knowledge to drive product yield and performance
$140,000 - $175,600 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.
