Technical Lead, NPI Manufacturing Engineer

Noah Medical•San Jose, CA

About The Position

Noah Medical is seeking a Technical Lead, NPI Manufacturing Engineer to provide leadership and guidance to the Manufacturing Engineering team through new product introduction and sustaining. The role manages manufacturing engineering processes, improvements, and time-based deliverables, and applies lean manufacturing, continuous improvement, and data analytics to improve productivity and reduce process costs. The position develops and improves manufacturing processes and procedures, supports product field-return strategies, and escalates and resolves design, manufacturability, quality, and supply-chain issues. It establishes DMR/DHR/LHR management for a complex system and develops workflow diagrams, manufacturing and shipping work instructions, procedures, checklists, travelers, and product and equipment maintenance plans. The role also proposes floor and line layouts, participates in BOM management and technical specification reviews, leads PFMEA activities, and develops and validates production tests. The Technical Lead oversees manufacturing equipment and process validation and qualification using IQ/OQ/PQ approaches, manages validation plans, studies, and reports, and provides design-for-manufacturing feedback to R&D. Additional work includes investigating discrepant production components, assemblies, and field returns; assisting with assembly, testing, and troubleshooting; and providing leadership, training, and technical support to production technicians. The role supports Good Manufacturing Practices and the quality management system in accordance with FDA regulatory requirements and ISO 13485.

Requirements

At least a four-year 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, or in a highly regulated manufacturing environment.
At least 5 years of manufacturing engineering experience with 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 NPI through sustaining.
Manage manufacturing engineering processes, improvements, and execution of time-based deliverables.
Implement lean manufacturing principles and continuous improvement initiatives, and use data analytics to improve operations, productivity, and process cost.
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 process 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 effective 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.
Oversee validation and qualification of manufacturing equipment and processes using standard IQ/OQ/PQ approaches.
Manage the development and delivery of validation plans, studies, and reports.
Provide feedback to R&D on product and process design-for-manufacturing improvements to support manufacturability and serviceability.
Provide technical support for analysis or investigation of 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 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 pay
Health insurance, including medical, dental, and vision coverage, with HSA and FSA options
401(k)
Stock purchase plans
Equity and bonus program
Tuition reimbursement
Paid time off and holidays
Flexible approach to work schedules, with remote, hybrid, field, or office arrangements where applicable
Company-paid and supplemental life insurance
Disability insurance
Mental health support through medical insurance programs
Legal insurance
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
On-demand online training and book reimbursement
Team-building and company-organized social and celebration events