Director, Quality NPD Engineering
Quality – Quality /
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 managerial position with s significant hands-on component. The right candidate will be able to adapt quickly to changing priorities and manage multiple projects and personnel simultaneously. He/she will provide lead the maintenance and improvement of the ReCor product development processes. He/she will provide support to ensure delivery of the safest and highest quality products while maintaining full regulatory compliance.
Responsibilities including but not limited to:
- Support company goals and objectives, policies and procedures
- Drive the execution and documentation of all Product Development efforts from concept to market release and beyond for multiple development projects
- Support the identification, refinement, definition, and justification for product requirements
- Drive updating the risk management files throughout the design control process and ensuring risk management is effective
- Guide the product development process to make key decisions based on risk
- Support the timely creation and/or revising of design verification and validation test plans, protocols, procedures and reports
- Lead, teach, coach, and train the organization on the requirements of the design control
- Revise and create procedures to maintain compliance and effectiveness of the design control process
- Foster an atmosphere of cross functional collaboration, support, and respect
- Set priorities for the quality new product development team
- Hire, train, coach, and develop a team of quality engineers that facilitate compliant, effective, and efficient product development.
- Step in to support other areas of the quality management system including quality systems, and quality production engineering as required
- BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, or related technical discipline preferred
- Minimum of 15 years as in the related field
- Minimum of 10 years in a management position
- Must have experience in medical devices with understanding of domestic and international regulatory standards (i.e. FDA QSR, ISO 13485 and MDD/MDR)
- Expertise in design controls, process validation, statistics and design of experiments
- Experience in ISO 14971 Risk Management for medical devices desired
- Self-motivated, team-oriented and flexible
- Effective interpersonal skills, ability to guide and influence others
- Effective verbal and written communication skills; ability to write clear procedures
- Exhibit good problem solving and analytical skills
- Exhibit effective project planning and organization skills
- Proficient in the use of Microsoft Office Suite and statistical software (i.e. Statgraphics, Minitab, etc.)
$209,000 - $241,000 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.