Technical Lead, NPI Manufacturing Engineer

NOAH Medical; San Jose (CA); On-site; USD 124,000 - 155,000; Full time

Benefits offered by this job

Health insurance

401K and stock purchase plans

Tuition reimbursement

Paid time off and holidays

Remote/hybrid/onsite options dependent

Job summary

Noah Medical is advancing a robotic platform for diagnostic and therapeutic applications in San Jose, CA. We seek a Technical Lead, NPI Manufacturing Engineer to guide the Manufacturing Engineering team through new product introductions and sustaining operations, driving process excellence and cost reduction.

The role requires a four-year engineering degree, 5+ years in manufacturing of complex devices, and strong collaboration with R&D and suppliers to ensure manufacturability and quality in a

Qualifications

• Requires a four-year degree in industrial or mechanical engineering or equivalent in medical devices with QSR/FDA ISO 13485:2016 or in a highly regulated manufacturing environment.
• Minimum of 5 years of experience in manufacturing engineering of complex electromechanical devices and medical devices.
• Ability to read and interpret assembly drawings, BOMs, workflow diagrams, MPIs, and basic schematics.
• Strong written and verbal communication skills with all levels of employees, suppliers, and internal customers.
• Demonstrates ability to grow in career.

Responsibilities

• Provide leadership and guidance to the ME team during NPI or sustaining phases.
• Manage ME processes, improvements, and time-based deliverables.
• Apply lean manufacturing principles to drive continuous improvement and reduce costs.
• Develop and improve ME processes and procedures.
• Support validation and qualification of manufacturing equipment and processes (IQ/OQ/PQ).
• Lead PFMEA activities and develop critical tests for production workflows.

Skills

Leadership

Data analytics

Lean manufacturing

Problem solving

Verbal & written communication

Career growth potential

Education

Bachelor's degree in industrial or mechanical engineering

Tools

PFMEA

IQ/OQ/PQ

BOM management

Job description

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Noah Medical’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.