Process Control Manager, Manufacturing
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 which will lead the advancement of commercial controls and readiness activities for Recor suppliers and manufacturing to ensure product quality, operational efficiency, and support data-driven decisions. Position reports to the Sr Manager, Process Control and may supervise engineers.
Responsibilities and Duties
- Duties and responsibilities include, but are not limited to:
- Manage the design and implementation of control programs for Operations, including facilities, supply chain, manufacturing, and external suppliers, as needed
- Build and manage staff for execution of process control and monitoring requirements and improvements
- Manage the Process Control/Monitoring program, including:
- Development and maintenance of process monitoring plan (including supplier processes)
- Statistical Process Control (SPC) creation, monitoring, and response to SPC events; able to drive root cause assessments and corrective actions efficiently and effectively
- Ensuring strong supplier controls including driving process characterizations, supporting process validations, and reviewing and providing input in process instructions
- Manage the support of sustaining engineering objectives, including:
- Collaborating with Production/Manufacturing Engineering to assess potential control methods/ recommendations for control improvements
- Building quality into processes via specifications/work instructions
- Test method validations
- Maintaining process risk documentation as well as drive updates to suppliers’ risk documentation, as necessary
- Determining qualification requirements for second suppliers / process updates
- Participation in definition and configuration of electronic manufacturing support software such as LHR, MES systems, barcoding
- Manage the completion New Product Introduction deliverables, such as:
- Test Method alignment with suppliers
- Master Validation Plan development and maintenance
- Manufacturing control: review / update traveler, ensure supporting documents are appropriate for guiding manufacture
- Monitor training effectiveness and implement training standards for manufacturing
- Identify and seek feedback from other functions to develop scalable and efficient control solutions
- Must execute work in a manner complaint with FDA and ISO regulations for medical device development and manufacture
- Must be a cooperative, engaged, hands-on leader
Requirements
- BS in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Process Engineering, or related technical discipline
- Must have 7+ years of experience in a regulated environment such as medical devices
- Minimum 2 years management experience
- MES system experience preferred
- Both capital equipment and disposable experience preferred
- Must have a strong background in statistics
- Must have the ability to multi-task in a fast-paced environment and respond to changing priorities
- Excellent communication and organization skills
$150,900 - $176,700 a year
Commensurate with experience, training etc.
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.
