Head of Operations and Manufacturing - Medical Device (Hybrid or Remote)

Head Of Operations And Manufacturing

The Head Of Operations And Manufacturing Will Own The End-To-End Operational Infrastructure Required To Bring Our FDA-Regulated Cuffless Blood Pressure Monitor To Market And Scale Production. This Is A Hands-On Leadership Role For Someone Who Thrives Building From Zero To One In A Regulated Environment: Selecting Contract Manufacturers, Standing Up Supply Chains Compliant With FDA 21 CFR Part 820, Establishing ISO 13485-Certified Quality Management Systems, And Preparing For Direct-To-Patient Fulfillment.

As A Company Preparing For 510(k) Submission And Commercial Launch, This Role Is Critical To Ensuring We Can Reliably Manufacture And Deliver A High-Quality, FDA-Cleared Medical Device At Scale. The Ideal Candidate Brings Deep Experience In Medical Device Manufacturing (Particularly Wearable Or Electro-Optical Devices), Understands Regulated Hardware Supply Chains And Design Transfer, And Can Roll Up Their Sleeves While Building The Team And Processes For Long-Term Growth.

This Position Reports Directly To The CEO With High Visibility To The Leadership Team And Board Of Directors.

Key Responsibilities

• Lead Selection And Onboarding Of Contract Manufacturing Partners With Class II Medical Device Experience, Including RFQ, Quality Audits, Contract Negotiation, And Ongoing Management.
• Own Design Transfer And Manufacturing Transfer, Working With Engineering On DFM Principles, Device Master Record (DMR) Requirements, And Production Readiness.
• Establish Production Planning, Forecasting, And Capacity Management For V&V Builds, Pilot Production, And Volume Manufacturing.
• Drive Continuous Improvement In Yield, Quality, And Cost While Maintaining FDA And ISO Compliance.
• Oversee Pilot Runs And Scale-Up, Including Process Validation (IQ/OQ/PQ) And Manufacturing Controls.

• Build And Manage The End-To-End Supply Chain, Including Component Sourcing, Supplier Qualification, And Inventory Management Per FDA Purchasing Controls.
• Develop Supplier Relationships And Negotiate Terms While Ensuring Supply Continuity, Traceability, And Risk Mitigation.
• Implement Inventory Planning To Balance Working Capital With Service Levels, Including Buffer Strategies For Year 1 Launch.
• Monitor And Mitigate Supply Chain Risks: Component Shortages, Single-Source Dependencies, Geopolitical Factors, And Logistics Disruptions.

• Maintain And Improve The ISO 13485-Certified QMS In Partnership With The Quality And Regulatory Team, Ensuring FDA 21 CFR Part 820 Compliance.
• Support 510(k) Submission Activities Related To Manufacturing, Including Process Validation Documentation, DMR Development, And Device History Records (DHR).
• Define Incoming Inspection, In-Process Controls, And Final Product Testing Consistent With The Risk Management File.
• Manage Product Certifications For A Class II Device, Including FDA Registration, UDI Compliance, And Applicable International Requirements.
• Lead Root Cause Analysis And CAPA For Quality Issues, Ensuring Post-Market Surveillance Compliance.

• Design The Direct-To-Patient Fulfillment Strategy, Including 3PL Selection With FDA-Cleared Class II Device Experience.
• Establish Logistics And Distribution For Nationwide Shipping Of A Regulated Device With Chain-Of-Custody And Traceability.
• Develop Returns, Replacement, And Warranty Processes That Balance Patient Experience, Cost, And Compliance.

• Start As An Individual Contributor Who Executes Hands-On, Then Build And Lead The Operations Team Through 510(k) Clearance And Commercial Launch.
• Establish Operational Metrics And Dashboards For Manufacturing, Supply Chain, And Quality Performance.
• Partner With Finance On Cost Modeling, COGS Optimization, And Operational Budgeting.
• Collaborate Cross-Functionally With Engineering, Software, Regulatory, And Commercial Teams.

Qualifications

• 7-12 Years In Manufacturing, Operations, Or Supply Chain, With 3-5+ Years In Medical Devices (Class II Preferred), Wearables, Or Regulated Hardware.
• Experience Managing Contract Manufacturers For Regulated Medical Devices, Preferably In Asia And/Or Domestically.
• Experience At Or With CMs/EMS Providers (Flex, Jabil, Celestica, Plexus, Sanmina) In Class II Medical Device Or Wearable Programs Is A Strong Plus.
• Track Record Of Design Transfer And Scaling Production From Pilot To Volume For Regulated Products.
• ISO 13485 And FDA 21 CFR Part 820 Experience Required.
• Familiarity With The 510(k) Process And Manufacturing Documentation (Process Validations, DMR/DHR) Strongly Preferred.
• Bachelor's In Engineering, Supply Chain, Operations, Biomedical Engineering, Or Related Field; MBA Or Advanced Degree A Plus.
• Based In California Or Travel Up To 25%.

Compensation

• Base Salary: $160,000 - $210,000 USD
• Performance Bonus: Tied To Company Milestones And Personal Objectives
• Equity: Early-Stage Stock Option Grant With Meaningful Ownership
• 100% Employer-Paid Healthcare: Medical, Dental, And Vision
• Additional Benefits: 401(k) With Company Match, Flexible PTO

Working Conditions:

• May OnOccasion Be Exposed To Loud Sounds And Distracting Noise Levels, Such As From Office Equipment.
• The Ability To Lift Up To 30lbs
• Use Of Computers And Technology