Noah Medical

Medical robotics system for lung diagnostics

Technical Lead - NPI Manufacturing Engineer

Manufacturing EngineeringConfirmed live in the last 24 hours

Full-timeSan Jose, CA, USA

About the Job

Requirements

A bachelor's degree in industrial or mechanical engineering, or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2016 or in a highly regulated manufacturing environment.
A minimum of 5 years of experience in manufacturing engineering of complex electromechanical devices and medical devices.
Ability to read and understand assembly drawings, bills of materials, workflow diagrams, and manufacturing process instructions, and to read basic schematics.
Good written and verbal communication with employees at all levels, suppliers, and internal customers.

Responsibilities

Provide leadership and guidance to the Manufacturing Engineering team during new product introduction through sustaining.
Manage Manufacturing Engineering processes, improvements, and execution of time-based deliverables.
Implement lean manufacturing principles, drive continuous improvement initiatives, and use data analytics to streamline Manufacturing Engineering operations, increase productivity, and reduce process costs.
Create and improve processes and procedures for Manufacturing Engineering and related areas.
Apply theoretical, analytical, and practical skills to resolve manufacturing issues.
Develop and support effective product field-return strategies and procedures.
Escalate and resolve design, manufacturability, quality, and supply chain issues.
Set up design, device, and lot history record management for a complex system.
Create workflow process diagrams, detailed manufacturing and shipping work instructions, procedures, checklists, travelers, and product and equipment maintenance plans.
Develop floor and line layout proposals for build capacity, quality, time optimization, and effective inventory management.
Participate in bill of materials management, technical specification reviews, and new part requisitions.
Lead process failure mode and effects analysis activities.
Develop and validate critical tests used in production workflows to minimize risk.
Perform validation and qualification activities for manufacturing equipment and processes using standard qualification approaches, including installation, operational, and performance qualification.
Manage the development and delivery of completed validation plans, studies, and reports.
Provide feedback to Research and Development for product and process design-for-manufacturability improvements to ensure optimal manufacturability and serviceability.
Provide technical support in analyzing or investigating discrepant production components, assemblies, and field returns.
Assist with assembly, testing, and troubleshooting of new products.
Provide leadership, training, and technical support to production technicians.
Implement fixtures to aid in production, maintenance, and service.
Support Good Manufacturing Practices and the quality management system in accordance with FDA regulatory requirements and ISO 13485.

Who We Are

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

About You

Provide leadership and guidance to the Manufacturing Engineering team (ME) during NPI New Product Introduction through sustaining.

Manages ME processes, improvements, and execution of time based deliverables

Implement lean manufacturing principles, drive continuous improvement initiatives, and utilize data analytics to streamline ME operations, increase productivity, and reduce cost in processes.

Creates and improves processes and procedures for ME and related areas.

Excellent theoretical, analytical, and practical skills; appropriately applied to resolving manufacturing issues.

Develops and supports effective product field returns strategy and procedures

Escalates and resolves design, manufacturability, quality, and supply chain issues

Responsible for setting up DMR/DHR/LHR management for a complex system

Creates workflow process diagrams, detailed manufacturing and shipping work instructions, procedures, checklists, travelers, product and equipment maintenance plans

Develops floor and line layout proposals for build capacity, quality, time optimization and effective inventory management

Participates in BOM management, technical specification reviews, new part requisitions

Leads process failure mode and analysis (PFMEA) activities

Develops and validates critical tests used in production workflow to minimize risk

Responsible for the activities of validation and qualification of manufacturing equipment and processes utilizing standard qualification approaches (IQ/OQ/PQ)

Manages development and delivery of completed validation plans, studies, and reports

Provides feedback for product and process DFM improvements to R&D to ensure optimal manufacturability and serviceability

Provides technical support in analyzing and/or performing investigation for discrepant production components, assemblies, and field returns

Assists with assembly, testing, and troubleshooting of new products

Provides leadership, training, and technical support to production technicians

Implements fixtures to aid in production, maintenance, and service

Support Good Manufacturing Practices and quality management system in accordance with FDA regulatory and ISO 13485 requirements.
Other related duties.

Qualifications

Minimum a four-year degree (Bachelor’s) in industrial or mechanical engineering or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2016 or in a highly regulated manufacturing environment

Need a minimum of 5 years of experience in manufacturing engineering of complex electromechanical devices and medical device

Must be able to read and understand assembly drawings, BOMs, workflow diagrams, MPIs, and read basic schematics

Good written and verbal communication skills with all levels of employees, suppliers, and internal customers

Demonstrates ability to grow in career

#LI-Onsite

Pay Transparency

The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.

California Pay Range

$124,000—$155,000 USD

Benefits & Perks (For Full Time Employees):

Competitive Salary
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, Flexible Time Off + Sick Time
Paid parental leave
In-office snacks and beverages
In-office lunch stipend
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events

Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.

Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.

Please visit our Careers Page to view our latest openings.

NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.

California Pay Range 124000 - 155000 USD

About the Company

Noah Medical

Medical robotics system for lung diagnostics

NoahMed develops medical robotics systems for pulmonology, focusing on early diagnosis. Its flagship Galaxy System with TiLT+ Technology mitigates CT-to-body divergence to improve diagnostic yield and provides real-time navigation updates in all lung areas. It features an augmented fluoro overlay that guides locating non-visual lesions and a single-use bronchoscope with accessories to reduce cross-contamination and speed turnover, all in a compact, single-cart design for crowded operating rooms. The company differentiates itself through TiLT+ navigation, real-time augmented guidance, and a disposable—rather than reprocessed—bronchoscope setup, aiming to improve diagnostic confidence and efficiency. Its goal is to enhance early lung diagnosis with more reliable guidance, reducing procedure time and improving outcomes for patients in collaboration with interventional pulmonologists.

Company size: 201-500
Company stage: Series B
Total funding: $150M
Headquarters: Redwood City, CA
Founded: 2018

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