Field Service & Operations Consulting

BUILT TO PERFORM.

Senior-level field service leadership for medical device and biomedical companies — from pre-launch startups to established global organizations. Based in Milford, CT. Available nationwide and remote.

35+
Years Experience
30+
Countries Served
FDA
Drug-Device Audits
35+
Years of
Expertise
Field Service Operations FDA 21 CFR Part 820 ISO 13485 Compliance Drug-Device Combination Audits Global Service Leadership Fractional Head of Service Startup Launch Services Depot Repair & Escalation Management Field Service Operations FDA 21 CFR Part 820 ISO 13485 Compliance Drug-Device Combination Audits Global Service Leadership Fractional Head of Service Startup Launch Services Depot Repair & Escalation Management

EXPERT SERVICES.
REAL RESULTS.

01
⚙️

Field Service Operations

End-to-end design and optimization of your field service organization — built to reduce downtime, improve response times, and scale with your growth.

  • SOPs, work instructions & escalation workflows
  • SLA design and performance metrics (KPIs/dashboards)
  • Depot repair setup and spare parts strategy
  • CRM selection, configuration & team rollout
  • Field engineer scheduling and dispatch processes
🗺️ Available in the Field — Nationwide & Global
Direct, hands-on support for equipment installations, IQ/OQ validation, customer & operator training, and full hospital integration — from Biomed department through to the surgical suite. Available throughout the U.S. and internationally.
02
📋

Regulatory Compliance

Get audit-ready and stay compliant — whether you're facing your first FDA inspection or closing gaps ahead of an ISO 13485 recertification.

  • FDA 21 CFR Part 820 & drug-device combo audit prep
  • ISO 13485 gap assessments and remediation plans
  • CAPA development and complaint handling systems
  • Service record documentation and DHR compliance
  • Mock audits and inspector-readiness coaching
03
🚀

Startup Service Buildout

Everything you need to launch a compliant, professional service organization — built from scratch, FDA-ready from day one.

  • Full service infrastructure design pre-commercialization
  • Complaint handling and MDR reporting processes
  • Depot repair, loaner fleet & returns management
  • Field engineer hiring profiles and onboarding plans
  • Customer support model and service contract templates
Startup Focused
04
👤

Fractional Head of Service

Director-level service leadership on a part-time contract basis — so you get senior expertise without the cost of a full-time executive hire.

  • Ongoing strategic oversight of your service organization
  • Attend leadership, board, or investor meetings as needed
  • Manage field engineers, vendors & service partners
  • Own compliance, quality events & customer escalations
  • Recruit and transition to a full-time hire when ready
Startup Focused
05
🌐

Global Service Programs

Expand internationally with service infrastructure that works across borders — built on 35+ years of managing teams and partners in 30+ countries.

  • Distributor and service partner network design
  • International service agreements and performance standards
  • Cross-border spare parts logistics and depot strategy
  • Regional compliance alignment (CE, MDR, local regulations)
  • Global field team structure, roles & reporting frameworks
06
🎓

Technical Training

Build a knowledgeable, confident service team — from day-one onboarding to advanced troubleshooting programs for complex regulated equipment.

  • Field engineer onboarding curriculum and competency sign-offs
  • Distributor and service partner training programs
  • Customer operator and end-user training materials
  • Training documentation compliant with 21 CFR Part 820
  • Train-the-trainer programs for international scale
Who We Serve

TWO MARKETS.
ONE EXPERT.

Mid-Size Companies

Established & Growing Organizations

Medical device and biomedical companies with 50–500 employees facing operational challenges, compliance pressure, or leadership gaps in their service organization.

  • Preparing for an FDA or ISO 13485 audit with compliance gaps
  • High equipment downtime or unresolved field service inefficiencies
  • Expanding internationally without global service infrastructure
  • Between senior service hires and need interim leadership
  • CRM or service management system needs an overhaul
Discuss Your Needs →
Startups — Any Stage

Pre-Launch to Early Commercial

Early-stage medical device companies approaching or post-FDA clearance that need to build a service organization from scratch — without the cost of a full-time executive.

  • Approaching first commercial launch with no service org in place
  • Need service infrastructure that's FDA-compliant from day one
  • Want a fractional Head of Service until ready to hire full-time
  • Series A–C funded and scaling from pilot to full deployment
  • Facing first field complaints with no escalation process
Build Your Service Org →
The Consultant

EXPERIENCE THAT
MOVES THE NEEDLE.

PATRICK
BAXTER
Principal Consultant
35+ years in field service & operations
Global teams across 30+ countries
Medical Device, Biomedical & Semiconductor
ISO 13485 | FDA 21 CFR Part 820
Milford, CT — Northeast U.S. & Remote
⭐ Key Differentiator
Successfully guided a company's Field Service Operations department through an FDA drug-device combination audit — one of the most complex inspection processes in the industry, requiring simultaneous compliance with 21 CFR Part 820 and drug GMP standards.

I'm a field service and operations leader with over 35 years of experience building, scaling, and optimizing service organizations across the medical device, biomedical, and semiconductor industries. My career spans both hands-on technical work and executive leadership — giving me the rare ability to engage at the strategic level and the shop floor simultaneously.

I've managed service teams across 30+ countries, implemented CRM systems from the ground up, guided companies through successful FDA inspections, and built service organizations that reduce downtime, improve compliance, and deliver measurable customer satisfaction. Every client I work with gets direct access to me — not junior staff.

2024 – Present
Independent Consultant
Baxter Field Solutions — Milford, CT
2021 – 2023
Director of Service Operations
Defibtech, LLC — Branford, CT
2020 – 2021
National Service Manager
Yushin America — Cranston, RI
2016 – 2020
Director, ATF Service
Repligen Corporation — Waltham, MA
2014 – 2016
Global Technical Service Manager
Avedro, Inc. — Waltham, MA
2013 – 2014
Field Service Manager
NinePoint Medical — Greater Boston
2008 – 2013
Service Manager
Avedro, Inc. — Waltham, MA
2006 – 2008
Service Manager
Omni Guide — Cambridge, MA
1988 – 2005
Applications Engineer
Helix Technologies — Asia-Pacific

LET'S TALK ABOUT YOUR SERVICE CHALLENGES.

Whether you're a startup building from scratch or an established company looking to improve operations, I'd love to hear what you're working on. Most engagements start with a straightforward conversation.

📍
Milford, Connecticut — Northeast U.S. & Remote
🔗
linkedin.com/in/patrick-baxter-8567861
Available for immediate engagement

I typically respond within one business day.