Sr. Industrial Engineer - Manufacturing
Noah Medical · San Jose, CA · 2 wk ago
On-siteManagement$106k–$133k/yrFull-time
About the role
The Senior Industrial Engineer – Manufacturing will serve as a strategic leader responsible for designing, building out, and continuously improving our manufacturing production facility. This role partners closely with cross-functional teams to develop scalable production processes, drive facility expansion projects from concept through completion, and ensure our operations meet the rigorous standards required for medical robotic devices. This is a hands-on leadership role with broad ownership of facility infrastructure, production flow, and operational efficiency.
Responsibilities
- Develop and implement scalable manufacturing processes and workflows for disposables and capital robotic systems, from pre-production through full-rate manufacturing.
- Own project management for all facility and IE-related initiatives: define scope, create schedules, manage budgets, track milestones, and report status to senior leadership.
- Provide leadership for planning, design, and build-out of new manufacturing production facilities, including space planning, utility requirements and equipment layout.
- Conduct line balancing, cycle time analysis, and capacity planning to meet production demand and support NPI (New Product Introduction) programs.
- Perform workflow and value-stream mapping; identify and eliminate bottlenecks to improve throughput, yield, quality, and cost.
- Define and validate manufacturing processes in accordance with FDA/ISO requirements for medical device production (IQ/OQ/PQ protocols, process FMEAs, control plans).
- Lead 6S/Lean transformation efforts across the facility; establish metrics, sustain gains, and build a culture of continuous improvement.
- Specify, procure, qualify, and integrate capital equipment and material handling systems into the production environment.
- Partner with Manufacturing Engineering, Quality, Supply Chain, and EHS to align facility design with regulatory, safety, and operational requirements.
- Maintain and improve engineering databases (WIPs, routings, BOMs) in NetSuite to support MRP accuracy and production planning.
- Develop AutoCAD/Revit facility drawings and maintain up-to-date layouts as operations evolve.
- Mentor junior Industrial Engineers and provide technical leadership across the IE team.
- Other duties as assigned consistent with the scope of this role.
Requirements
- BS or MS in Industrial Engineering, Manufacturing Engineering, or equivalent technical discipline.
- 7+ years of experience in industrial or manufacturing engineering, with at least 3 years in a senior or lead capacity.
- Demonstrated experience leading the build-out or significant expansion of a manufacturing production facility, including process development and validation.
- Formal project management experience (PMP certification or equivalent); proficiency with project scheduling tools (MS Project, Smartsheet, or similar).
- Strong proficiency in AutoCAD, Revit, or SolidWorks for facility layout and design.
- Deep knowledge of Lean manufacturing principles (value-stream mapping, kanban, kaizen, 6S) and hands-on experience implementing them at scale.
- Experience with medical device manufacturing regulations (FDA 21 CFR Part 820, ISO 13485) and process validation methodology (IQ/OQ/PQ) strongly preferred.
- Proven cross-functional leadership and the ability to influence without direct authority across engineering, quality, supply chain, and facilities teams.
Qualifications
- Proven experience in industrial or manufacturing engineering.
- Experience in project management and project scheduling tools.
- Proficiency in AutoCAD, Revit, or SolidWorks.
- Knowledge of Lean manufacturing principles and hands-on experience implementing them.
- Experience with medical device manufacturing regulations.
- Ability to influence and lead cross-functional teams.
Skills
- Project Management
- Manufacturing Process Development
- Facility Design and Layout
- Lean Manufacturing Principles
- Medical Device Manufacturing Regulations
- Team Leadership
Benefits
- 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