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.
Position Summary
The Sr. NPD Manufacturing Engineer is a core cross-functional member of the Ultrasound technology and systems operations team. This engineering position is responsible for developing and implementing product and process enhancements through adjustments to designs, processes, equipment, facilities, and standards. Additionally, it involves providing technical assistance on the production line. Reporting to the Manager of Ultrasound Technology and Systems, this position plays a pivotal role in driving improvements and ensuring company production objectives are met.
Responsibilities and Duties
- Develops new and enhances production processes at any stage of production from pilot to full-scale manufacturing.
- Leads process characterization and improvement activities (screening experiments, Test Method Validation design and protocol writing, DOE, process mapping for inputs/outputs, equipment design and selection).
- Designs and qualifies tooling, fixtures, and equipment. This may involve varying degrees of semi-automation.
- Compiles and evaluates test data to determine appropriate limits and variables for process or material specifications.
- Coordinates design requirement review with appropriate engineering/scientific personnel to ensure compatibility of processing methods.
- Identify and drive production capacity improvements.
- Creates manufacturing documentation (SOP’s, MPIs and records) through change order process.
- Creates and standardizes training programs for production operators.
- Leads PFMEA activities and contributes to other aspects of Risk Management.
- Conceives and plans projects involving definition and selection of new concepts, equipment automation technology, and approaches in the processing or development of new or improved processes.
- Leads and coordinates activities of technicians in support of equipment/process development, equipment/process trouble shooting, and custom equipment procurement.
- Contributes to developing partnerships with new suppliers. Performs supplier qualifications for 2nd sourcing of components (may involve component design changes).
- Familiar with Lean manufacturing principles and reduce waste and maximize the efficiency
Skills
- Develop, managing and implementing changes in a regulated production environment (e.g., FDA regulations, ISO 13485)
- Design, produce, document tools and fixtures for various assembly applications.
- Experience with designing and conducting Gage R&R studies and process validations.
- Hands on experience troubleshooting assembly production lines.
- Strong communication and collaboration skills to work effectively with internal and external stakeholders.
Requirements
- Bachelor’s degree in engineering: Mechanical, Industrial, Manufacturing and Process disciplines will be considered.
- At least 6+ years of Manufacturing Engineering experience with process design, development, and improvement.
- At least 5 years’ experience in medical Device Industry is a MUST.
- Must have prior experience directly supporting Medical Device Manufacturing (troubleshooting, safety improvements, operator training, process control plans, NCMR dispositions.)
- Proficient with MS Office and basic statistics
- Experience creating sketches, CAD drawings.
#LI-AS1
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.
