Fractional Automation Engineer for Medical Device Manufacturers
Most medical device manufacturers hit the same wall when it’s time to automate. Management issues the directive. The team looks around. Nobody on staff has run an automation procurement project with GAMP documentation from start to finish.
The senior engineer who did retired two years ago or moved to a larger company. The junior engineer who’s been assigned the project has never written a URS. There are two standard responses to this problem. Both have costs most companies underestimate.
The Two Traps
Hire a full-time senior automation engineer
A senior automation engineer with real GAMP experience in FDA-regulated manufacturing costs $150–210k+ loaded, salary, benefits, taxes, overhead. The role typically sits open 60–120 days with no qualified applicants.
When the project ends, the company carries that salary with nothing to assign. Senior engineers in this niche leave when there’s no project pipeline. They take the institutional knowledge with them.
Assign it to a junior engineer, or let the vendor handle it
A junior engineer costs less per hour. But the total cost is higher than it looks. Steeper learning curve. More effort per deliverable. Less pattern recognition means more mistakes that require rework. And the GMP compliance risk is real: a junior engineer who doesn’t know what a solid URS looks like can create 483 exposure your quality team will spend months cleaning up.
Letting the vendor handle the GAMP documentation has its own problem. Vendors build equipment. GAMP documentation isn’t their core competency. You end up with documentation assembled after the fact by someone who wasn’t there.
The Fractional Model
A fractional automation engineer sits between these two failure modes.
MEPSCo embeds with the manufacturer’s team for the duration of the project. We manage the full equipment procurement lifecycle, from the first customer interview through IQ/OQ/PQ and knowledge transfer to the internal team. When the equipment is validated and running, we move on. The junior engineer takes over sustaining activities.
No $180k+ salary between projects. No 60–120 day hiring delay. No attrition risk. Starts in days, not months. 96+ projects of pattern recognition behind every decision.
“You have to pay for the experience. You hire me, I’m going to do the work and get out, then the junior engineer takes over.”
REZA BASHAR
Some people search for this role under a different name. Automation consultant. Automation engineering consultant. Medical device manufacturing consultant. All of them point at the same work. What’s different is whether the person behind the title brings a defined, repeatable process or figures it out project by project. Fractional Automation Engineer vs. Automation Consultant covers that distinction in detail.
What a Fractional Engagement Covers
The full equipment procurement lifecycle, or any part of it.
Requirements
Customer Requirements Document, stakeholder interviews, Budgetary URS, budgetary vendor quotes. Management gets a real number before committing to procurement.
Procurement
Final URS development, vendor scoring and selection using Kepner-Tregoe methodology, vendor management through the build. The spec prevents the surprise.
Acceptance Testing
Factory and Site Acceptance Testing. Test method and document development. Punch list management. Every requirement verified before the equipment ships.
Qualification
IQ/OQ/PQ documentation and execution support. Engineering studies. Validation plan. Trace matrix from URS through PQ. Built for FDA scrutiny, not assembled after the fact.
Transfer
Operator SOPs. PM SOPs. Junior engineer training. Knowledge transfer is a deliverable, not an add-on. When the engagement ends, the equipment is running and the team knows how to keep it that way.
Who This Is For
MEPSCo works with medical device manufacturers that are:
Specifically device-as-a-product companies in FDA-regulated manufacturing environments. Not device-as-a-component manufacturers. Not R&D-stage companies still defining the product.
Who This Is Not For
MEPSCo isn’t the right fit for every situation.
If your company has a full senior automation engineering bench with active GAMP documentation experience and a project pipeline to keep them engaged, you don’t need a fractional engineer. You need project coordination.
If your project is still in R&D and the product isn’t defined yet, the right first step is Proof of Principle or Proof of Concept work, not equipment procurement. MEPSCo can help with POP/POC, but a full procurement engagement before the product is finalized creates expensive rework.
The Economic Case
The comparison that matters isn’t hourly rate. It’s total project cost.
Replicate builds are priced significantly lower. The company pays for the project. Not the bench time. A properly written URS, the document that prevents change orders, is included in every MEPSCo engagement.
96+ completed equipment procurement and validation projects across 25 years in medical device manufacturing. Small builds (2 custom fill units for a CMO in under 2 months) to large-scale validated production ($150M in equipment qualified during COVID for a DOD contract with no change orders).
Named references: Matt Richard (Director of Manufacturing, Hologic), Adam Baeuer (Assembly Operations Manager, Philips Medisize), Dave Carlberg (Cofounder, Kinematic Automation).
Related Pages
GAMP Documentation Services
22 document types and the 8-step process behind every engagement.
READ MORE →Equipment Procurement & Vendor Management
Vendor scoring, selection and management through the build.
READ MORE →Fractional vs. Full-Time Hire
The cost comparison, line by line.
READ MORE →Fractional vs. Validation Consulting Firm
One engineer with a process, versus a deployed team.
READ MORE →Fractional vs. Automation Consultant
What the title does and doesn’t tell you.
READ MORE →Semi vs. Full Automation Decision Guide
Which model fits your production reality.
READ MORE →Common Questions
What does a fractional automation engineer actually do?
A fractional automation engineer manages the full equipment procurement and validation lifecycle for a medical device manufacturer on a project basis. That includes writing the URS, selecting and managing the automation vendor, overseeing FAT and SAT, providing IQ/OQ/PQ documentation, and transferring knowledge and SOPs to the internal team. The engagement ends when the equipment is validated and running.
How is a fractional automation engineer different from a contractor or staffing placement?
A contractor or staffing placement sends a person. A fractional automation engineer brings a process. MEPSCo comes with 96+ completed projects, 22 proprietary document types, 15+ automation vendor relationships built over 25 years, and a structured methodology for equipment procurement that has produced on-time, on-budget outcomes across projects from small CMO builds to a $150M DOD pandemic contract. A staffing agency sends a resume and hopes it works out.
How long does a fractional engagement typically last?
Engagement length depends on project scope and complexity. A Budgetary URS engagement typically runs weeks. A full procurement and qualification engagement, URS through IQ/OQ/PQ, runs months, aligned to the equipment build and qualification timeline. MEPSCo runs 3–4 concurrent projects at approximately 45–50 hours per week total across engagements.
Does MEPSCo work with automation vendors as well as manufacturers?
Yes. Automation vendors bring MEPSCo in when their manufacturer customers need GAMP documentation support the vendor can’t provide internally. The vendor protects the customer relationship, keeps the project clean, and closes contracts they might otherwise lose. MEPSCo also recommends qualified vendors to manufacturers through the structured vendor scoring process.
What types of medical device companies does MEPSCo work with?
Medical device manufacturers, diagnostics and IVD companies, and CDMOs, specifically device-as-a-product companies operating in FDA-regulated environments. MEPSCo does not work with device-as-a-component manufacturers. The distinction matters: device-as-a-product companies have direct FDA exposure on the finished product, which drives the GAMP documentation requirements that MEPSCo specializes in.
Can MEPSCo handle multiple projects at the same time?
Yes. MEPSCo runs 3–4 concurrent projects depending on size, complexity, and cadence, with a bench of contractors available for execution support on larger or concurrent projects. A Manufacturing Automation Assessment is the right starting point to discuss whether current capacity aligns with your project timeline.
Is a fractional automation engineer the same thing as an automation consultant?
Yes, and no. The search terms overlap. “Automation consultant” describes a wide range of arrangements, some hands-on, some advisory-only, some general industrial, some medical device specific. A fractional automation engineer at MEPSCo is a specific version of that: one senior engineer, a documented 8-step process, and hands-on execution rather than advice from the sidelines.
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