Staff Manufacturing Systems Engineer

Recor Medical, Inc.; Palo Alto (CA); On-site; USD 185,000 - 204,000; Full time

Job summary

Recor Medical, Inc. is seeking a biomedical/engineering specialist to design complete acoustic systems for the Paradise uRDN platform. You will integrate software, hardware, and mechanical aspects to meet device performance requirements.

The role includes leading software development for production, interfacing with microcontrollers, building an open-source framework, and ensuring IEC 81001-5-1 and IEC 62443 cybersecurity standards and FDA expectations are met across manufacturing operations.

Qualifications

• Master's degree in Biomedical or Computer Science Engineering.
• Experience with microcontroller programming.
• Proficiency in MATLAB, Python, C++ for software and instrument control.
• Experience with measurement systems to characterize complex acoustic and temperature fields.
• Knowledge of cybersecurity requirements for medical devices and manufacturing systems, including FDA expectations.

Responsibilities

• Lead development of computer programming systems and applications to meet production needs.
• Develop software and hardware communicating with microcontrollers/devices using Ethernet, serial, I2C, etc.
• Create a robust open-source software framework for systems used in production line.
• Execute test method validation to develop software requirements with cross-functional agreement.
• Generate and execute test plans, verification, and validation protocols.
• Collaborate with Quality, IT, Regulatory, and R&D teams to maintain cybersecurity compliance.

Skills

Microcontroller programming

Python

MATLAB

C++

Cybersecurity basics

Communication skills

Education

Master of Science in Biomedical / Computer Science Engineering

Tools

MATLAB

Python

C++

Job description

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.

Overview

This role involves the design of complete and complex acoustic systems. This requires functional development and integration of the software, hardware and mechanical aspects of product, systems, and components to ensure that the resulting functionality meets the device performance requirements of the acoustic system

Essential Job Functions

• Leads development of computer programming systems and applications including the design, coding, testing and deployment of products and solutions to meet production needs.
• Develops software and hardware that communicates with variety of microcontrollers / devices using ethernet, serial, One Wire, I2C protocols etc
• Create a robust open-source software framework and solution for systems used in production line.
• Execute test method validation to develop software requirement specification with cross functional agreement.
• Generating and executes test plans, verification, and validation protocols.
• Research and implement new methods and technologies to enhance operations.
• Assists process development in developing scalable processes with improved product yield and reduced costs for manufacturing systems.
• Working independently to identify and drive production capacity improvements by providing automation solutions.
• Develop medical device software by being compliant with IEC and other pertinent regulatory medical device standards.
• Integrate cybersecurity requirements into manufacturing software, hardware, and networked systems to support secure design, deployment, and maintenance of production equipment and test systems.
• Apply secure software development and change control practices, including cybersecurity documentation, verification, and traceability, in alignment with FDA expectations and applicable standards such as IEC 81001-5-1 and IEC 62443.
• Support vulnerability monitoring, patch evaluation, incident response, and remediation activities for manufacturing systems while minimizing disruption to validated production processes.
• Collaborate with Quality, IT, Regulatory, and R&D teams to maintain cybersecurity compliance, support audits, and promote cybersecurity awareness and best practices across production operations.
• Systematically analyze and solve complicated problems through electrical/acoustic/mechanical testing.
• Design test methods/procedures to characterize the electrical and acoustic system performance.
• Work with measurement systems such as function generator, oscilloscope, radiation force balance, hydrophone, motor systems to characterize complex acoustic and temperature fields.

Qualifications

• Master of Science degree in Biomedical / Computer Science Engineering with experience in medical device industry.
• Experience with microcontroller programming.
• Experience with MATLAB, Python, C++, other similar tools for software development and instrument control.
• Work with measurement systems such as function generator, oscilloscope, radiation force balance, hydrophone, motor systems to characterize complex acoustic and temperature fields.
• Identify problems or improvement opportunities in existing measurement methods, and system/transducer designs.
• Excellent oral and written communication skills.
• Self-motivated, action oriented and result oriented.
• Understanding of medical device processes and assembly knowledge to drive product yield and performance.
• Experience with cybersecurity requirements for medical device or manufacturing systems, including secure software development, risk assessment, access control, vulnerability management, and familiarity with FDA cybersecurity expectations, IEC 81001-5-1, and IEC 62443.

Salary Range

$184,900 - $204,000 (Annual Base Salary)

Compensation for this role is determined using market-based geographic pay ranges. The salary range offered to the selected candidate may vary based on their primary work location, relevant experience, qualifications, and other job-related factors.

The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.

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.

Pre-Employment Requirements

At Recor Medical, patient safety, integrity, and regulatory compliance are foundational to everything we do. To support these standards, employment is contingent upon meeting the following requirements:

• Background Screening & Drug Testing: Final candidates may be required to successfully complete a background check and/or drug screening, conducted in accordance with applicable laws and regulations.
• Washington Fair Chance Act Compliance (if applicable): For applicants who reside in or are applying for roles based in Washington State, Recor Medical adheres to the Washington Fair Chance Act. This means we do not inquire about or consider criminal history until after an initial determination has been made that the candidate is otherwise qualified for the role, and we do not automatically exclude individuals based on criminal records.
• New Hire Training: All employees are required to successfully complete Recor training program within their first 90 days of employment as a condition of continued employment.

Radiation Safety Requirement

Certain field-based roles at Recor Medical require work in environments where radiation sources (e.g., x-ray equipment) are in use. Employees in these roles will be issued a personal dosimetry badge to monitor occupational exposure and are required to wear it in accordance with company policy and applicable regulatory standards. This program is designed to ensure compliance with federal and state regulations and to maintain radiation exposure at levels that are As Low As Reasonably Achievable (ALARA). Additional guidance and protective equipment, as necessary, will be provided as part of onboarding and ongoing safety training.

Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.