Technical Lead, NPI Manufacturing Engineer

Noah Medical•San Jose, CA

10d•$124,000 - $155,000

About The Position

Noah Medical is hiring a Technical Lead, NPI Manufacturing Engineer to provide leadership and guidance to the Manufacturing Engineering team from new product introduction through sustaining. The role manages manufacturing engineering processes, improvements, and time-based deliverables, and applies lean manufacturing and data analytics to improve productivity, streamline operations, and reduce process costs. The position develops and improves manufacturing processes, procedures, documentation, layouts, and production support systems for complex medical-device products. It addresses design, manufacturability, quality, and supply-chain issues; supports investigation of production discrepancies and field returns; and works with R&D on design-for-manufacturing and serviceability improvements. The role also leads process risk analysis and production test development, and manages manufacturing equipment and process validation and qualification using IQ/OQ/PQ approaches. The Technical Lead provides technical support, training, and leadership to production technicians, assists with assembly, testing, and troubleshooting of new products, and implements production, maintenance, and service fixtures. The role supports Good Manufacturing Practices and the quality management system in accordance with FDA requirements and ISO 13485. The position is listed with a California pay range of $124,000–$155,000 USD. Noah Medical describes benefits for full-time employees and notes that remote, hybrid, or onsite arrangements within California may be offered depending on the team and role.

Requirements

Bachelor’s degree in industrial or mechanical engineering, or an equivalent combination of education and experience in medical devices with QSR/FDA and ISO 13485:2016 experience, or in a highly regulated manufacturing environment.
At least 5 years of experience in manufacturing engineering for complex electromechanical devices and medical devices.
Ability to read and understand assembly drawings, BOMs, workflow diagrams, and MPIs, and to read basic schematics.
Good written and verbal communication skills with employees at all levels, suppliers, and internal customers.
Demonstrated ability to grow in a career.

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, continuous improvement initiatives, and data analytics to streamline operations, increase productivity, and reduce process costs.
Create and improve processes and procedures for manufacturing engineering and related areas.
Develop and support product field-return strategies and procedures.
Escalate and resolve design, manufacturability, quality, and supply-chain issues.
Set up DMR/DHR/LHR management for a complex system.
Create workflow diagrams, manufacturing and shipping work instructions, procedures, checklists, travelers, and product and equipment maintenance plans.
Develop floor and line layout proposals to support build capacity, quality, time optimization, and inventory management.
Participate in BOM management, technical specification reviews, and new part requisitions.
Lead process failure mode and effects analysis (PFMEA) activities.
Develop and validate critical tests used in production workflows to minimize risk.
Manage validation and qualification activities for manufacturing equipment and processes using IQ/OQ/PQ approaches.
Manage development and delivery of completed validation plans, studies, and reports.
Provide R&D with feedback on product and process design-for-manufacturing improvements to support manufacturability and serviceability.
Provide technical support for 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 support production, maintenance, and service.
Support Good Manufacturing Practices and the quality management system in accordance with FDA regulatory requirements and ISO 13485.
Perform other related duties.

Benefits

Competitive salary and pay.
Health insurance, including medical, dental, and vision, with HSA and FSA options.
401(k) and stock purchase plans.
Equity and bonus program.
Company-paid and supplemental life insurance, and disability insurance.
Mental health support through medical insurance programs.
Legal and pet insurance.
12 or more paid holidays, flexible time off, and sick time.
Paid parental leave.
In-office snacks and beverages.
In-office lunch stipend.
Tuition reimbursement.
Learning and development opportunities, including on-demand online training and book reimbursement.
Team-building and company-organized social and celebration events.