Recor Medical
Senior Engineer, Process Control
Recor Medical, Palo Alto, California, United States, 94306
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 requires a dynamic individual capable of adapting quality to shifting priorities and managing multiple projects concurrently. The ideal candidate will work cross-functionally to drive advancements in process and reliability control across both on-site and off-site manufacturing environments. By leveraging statistical analysis and data-driven methodologies, they will systematically characterize processes and develop robust control plans that ensure product quality in a fast-paced environment. This role reports directly to the Manager of Process Control Engineering.
Responsibilities and Duties
Conduct hands-on characterization, qualification, documentation and implementation of manufacturing processes, equipment and tooling.Develop methods for the testing and monitoring of processes, technologies, and products to ensure consistent product quality from both contract manufacturers and internal manufacturing (such as statistical process controls).Analyze process and production data to identify issues; design and conduct experiments to uncover root causes. Implement corrective actions and manage verification plans to ensure their effectiveness.Develop and implement comprehensive reliability characterization and reliability testing strategies to ensure product durability and performance.Perform reliability tests, generate engineering reports, and update risk management documentation.Collaborate with cross-functional teams in characterization measurement equipment, including leading gage R&R and equipment capability analysis.New product scale-up, process optimization, technology transfer and process validation activities.Participate in the creation and continuous improvement of production procedures and product specifications to enhance and optimize process controls.Engage with cross-functional teams to develop scalable control systems for operational processes.Support production capacity and yield improvement activities.Assist in qualification of alternative supply sources or new vendors.May research and implement new methods and technologies to enhance operations.Must execute work in a manner compliant with FDA and ISO guidelines for medical device development and manufacture.Any additional duties as assigned.Requirements
Bachelor of science degree in engineering or related technical disciplines.Minimum 5 years in a regulated manufacturing environment such as medical devices with an understanding of domestic and international regulatory standards (i.e. FDA QSR, ISO 13485 and MDD/MDR).Proficient knowledge of design controls, process validation, statistics, reliability analysis, and design of experiments.Effective verbal and written communication skills; ability to write clear procedures.Strong problem solving and analytical skills.Self-motivated, collaborative, and result oriented.Proficient in statistical software such as JMP or Minitab.Proficient in the use of Microsoft Office Suite.Experience in supplier management and/or contract manufacturing control preferred.Willingness to travel up to 15% domestically.
$108,600 - $140,975 a year
Commensurate with experience, skills, education, and training.COVID-19 vaccination requirementsAt 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 OpportunityAt 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.ReCor Medical Applicant Privacy Policy
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Responsibilities and Duties
Conduct hands-on characterization, qualification, documentation and implementation of manufacturing processes, equipment and tooling.Develop methods for the testing and monitoring of processes, technologies, and products to ensure consistent product quality from both contract manufacturers and internal manufacturing (such as statistical process controls).Analyze process and production data to identify issues; design and conduct experiments to uncover root causes. Implement corrective actions and manage verification plans to ensure their effectiveness.Develop and implement comprehensive reliability characterization and reliability testing strategies to ensure product durability and performance.Perform reliability tests, generate engineering reports, and update risk management documentation.Collaborate with cross-functional teams in characterization measurement equipment, including leading gage R&R and equipment capability analysis.New product scale-up, process optimization, technology transfer and process validation activities.Participate in the creation and continuous improvement of production procedures and product specifications to enhance and optimize process controls.Engage with cross-functional teams to develop scalable control systems for operational processes.Support production capacity and yield improvement activities.Assist in qualification of alternative supply sources or new vendors.May research and implement new methods and technologies to enhance operations.Must execute work in a manner compliant with FDA and ISO guidelines for medical device development and manufacture.Any additional duties as assigned.Requirements
Bachelor of science degree in engineering or related technical disciplines.Minimum 5 years in a regulated manufacturing environment such as medical devices with an understanding of domestic and international regulatory standards (i.e. FDA QSR, ISO 13485 and MDD/MDR).Proficient knowledge of design controls, process validation, statistics, reliability analysis, and design of experiments.Effective verbal and written communication skills; ability to write clear procedures.Strong problem solving and analytical skills.Self-motivated, collaborative, and result oriented.Proficient in statistical software such as JMP or Minitab.Proficient in the use of Microsoft Office Suite.Experience in supplier management and/or contract manufacturing control preferred.Willingness to travel up to 15% domestically.
$108,600 - $140,975 a year
Commensurate with experience, skills, education, and training.COVID-19 vaccination requirementsAt 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 OpportunityAt 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.ReCor Medical Applicant Privacy Policy
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