Staff Manufacturing Engineer

Recor Medical; Palo Alto (CA); On-site; USD 141,000 - 176,000; Full time

Job summary

An innovative company is seeking a Staff Manufacturing Engineer to join their Ultrasound technology team. This pivotal role involves enhancing production processes and ensuring compliance with industry standards. You will collaborate with cross-functional teams to drive improvements in manufacturing efficiency and quality. If you are passionate about making a difference in the medical field and have extensive experience in manufacturing engineering, this opportunity offers you the chance to impact lives positively. Join a mission-driven organization dedicated to providing non-invasive solutions for hypertension treatment.

Qualifications

• 8+ years of experience in Medical Manufacturing Engineering.
• Proficient in process design, development, and improvement.

Responsibilities

• Develops and enhances production processes from pilot to full-scale manufacturing.
• Leads process characterization and improvement activities.
• Creates and standardizes training programs for production operators.

Skills

Regulated production environment management

Design and documentation of tools and fixtures

Gage R&R studies and process validations

Troubleshooting assembly production lines

Strong communication and collaboration skills

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Industrial Engineering

Bachelor’s degree in Manufacturing Engineering

Bachelor’s degree in Process Engineering

Tools

MS Office

CAD software

Job description

Join to apply for the Staff Manufacturing Engineer role at Recor Medical.

Get AI-powered advice on this job and more exclusive features.

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 Staff 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.

Skills

• Develop, manage, and implement 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.

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, potentially involving 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 processing method compatibility.
• Identify and drive production capacity improvements.
• Creates manufacturing documentation (SOPs, MPIs, records) through change order process.
• Creates and standardizes training programs for production operators.
• Leads PFMEA activities and contributes to other aspects of Risk Management.
• Plans projects involving new concepts, equipment automation, and process improvements.
• Leads and coordinates activities of technicians in support of equipment/process development and troubleshooting.
• Develops partnerships with new suppliers and performs supplier qualifications.
• Familiar with Lean manufacturing principles to reduce waste and maximize efficiency.

Requirements

• Bachelor’s degree in Mechanical, Industrial, Manufacturing, or Process Engineering.
• At least 8+ years of Medical Manufacturing Engineering experience, including process design, development, and improvement.
• Experience supporting Medical Device Manufacturing, including troubleshooting, safety improvements, operator training, and process control plans.
• Proficient with MS Office and statistics.
• Experience creating sketches and CAD drawings.

Salary Range: $141,000 - $175,950 (Annual Base Salary). The starting pay will be based on skills, experience, and market conditions.

Equal Employment Opportunity

We value diversity and are committed to equal opportunity employment without discrimination based on race, color, religion, national origin, age, sex, disability, or other protected characteristics.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Engineering and Information Technology
• Industry: Medical Equipment Manufacturing