Technical Lead, NPI Manufacturing Engineer San Jose, California

Noah Medical; San Jose (CA); Híbrido; USD 124.000 - 155.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive health insurance (M,D,V)

Equity & Bonus Program

Life Insurance

Disability insurance

Mental health support

12+ paid holidays

Flexible Time Off

Paid parental leave

In-office snacks and beverages

Learning & Development opportunities

Team building events

Descripción de la vacante

Noah Medical in San Jose, CA is seeking a Technical Lead, NPI Manufacturing Engineer to lead the Manufacturing Engineering team during NPI and sustaining activities. The role focuses on implementing lean principles, driving improvements, and ensuring manufacturability across complex electromechanical medical devices.

The successful candidate will manage ME processes, systems, and deliverables, develop validation plans, and provide hands-on support to production teams, while aligning with FDA QSR

Formación

• Four-year degree in industrial or mechanical engineering.
• Minimum 5 years of experience in manufacturing engineering of complex electromechanical devices and medical devices.
• Ability to read assembly drawings, BOMs, workflow diagrams, MPIs, and basic schematics.
• Strong written and verbal communication with all levels of employees, suppliers, and internal customers.
• Demonstrates ability to grow in career.

Responsabilidades

• Provide leadership and guidance to the Manufacturing Engineering team during NPI through sustaining.
• Manage ME processes, improvements, and execution of time-based deliverables.
• Implement lean manufacturing principles and drive continuous improvement initiatives.
• Create and improve processes and procedures for ME and related areas.
• Develop and support effective product field returns strategy and procedures.
• Escalate and resolve design, manufacturability, quality, and supply chain issues.
• Lead PFMEA activities and validation/qualification of manufacturing equipment and processes.
• Provide technical support to production technicians and assist with assembly, testing, and troubleshooting of new products.
• Ensure compliance with FDA QSR/ISO 13485:2016 and related regulatory requirements.

Conocimientos

Leadership

Lean manufacturing

Data analytics

Project management

Communication skills

Mentoring

Educación

Bachelor’s degree in industrial or mechanical engineering

Descripción del empleo

Technical Lead, NPI Manufacturing Engineer

San Jose, California

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.

$124,000 - $155,000 USD

Benefits & Perks (For Full Time Employees):

• 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
• 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.