Bachelor's degree in industrial or mechanical engineering or equivalent experience in medical devices with QSR/FDA ISO 13485:2016.
Minimum of 5 years in manufacturing engineering for complex electromechanical devices and medical devices.
Ability to read and understand assembly drawings, BOMs, workflow diagrams, and basic schematics.
Strong written and verbal communication skills across all levels of the organization.
Demonstrated potential for career growth.
Responsibilities
Lead and guide the Manufacturing Engineering team during New Product Introduction (NPI) and sustaining phases.
Manage ME processes and ensure timely execution of deliverables.
Implement lean manufacturing principles and drive continuous improvement initiatives.
Create and enhance processes and procedures for Manufacturing Engineering.
Develop and support effective product field returns strategies and procedures.
Escalate and resolve design, manufacturability, quality, and supply chain issues.
Set up DMR/DHR/LHR management for complex systems.
Benefits
Comprehensive health insurance including Medical, Dental, and Vision with HSA and FSA options.
Equity and bonus program.
Life and disability insurance (company paid & supplemental).
Mental health support through medical insurance programs.
Flexible Time Off plus 12+ paid holidays and sick time.
Paid parental leave.
In-office snacks, beverages, and lunch stipend.
Learning and development opportunities including online training and book reimbursement.
Team building and company-organized social events.
Full Job Description
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
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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.
