Senior Software Quality Engineer (pathway to VP) – SaMD & Medical Device Compliance

Remote | Early-Stage MedTech Startup | Backed by a Public Company Portfolio

Hi reader. It is I, a human who wrote (some) of this. Do me a favor and at least read down to the "what's in it for you" section before you continue doom scrolling on whatever social media you find least aggravating.

Twelve10 (my recruitment company, not my end client, so please don't tell me how Twelve10's mission resonates with you using the AI template LinkedIn provides) has been retained by a private equity firm to build out the go-to-market (GTM) team for a groundbreaking medtech startup. If you’ve ever wanted to get in at the ground floor and shape compliance, validation, and quality processes for Software as a Medical Device (SaMD), this is your chance.

What's in it for you?

Define the Future of Quality in SaMD – Step into a startup before everything is set in stone. You’ll build, refine, and own quality systems, helping to shape how compliance and validation are handled from the ground up.
Clear path to VP- You'll be reporting directly into the CCO, the job title is fluid, perhaps you'll come in at Senior level, if you knock the interview out of the park, maybe even director. You knock the role oiut of the park over the next 24 months, VP is on the table.
Fully Remote & Backed by Stability – Work from anywhere in the U.S. while being part of an early-stage startup with the financial backing of a public company’s portfolio—so you get startup agility without the instability.
Make a Real Impact – This isn’t a cog-in-the-machine role. You’ll play a pivotal part in getting innovative medical technology to market, working across quality systems, product validation, and vendor management.
Mission-Driven Work – Join a team that’s improving patient outcomes with cutting-edge medical technology in wound & skin care.

What You’ll Be Doing

Build and maintain the Electronic Quality Management System (eQMS).
Ensure SaMD compliance with ISO 13485, ISO 14971, IEC 62304, and develop quality systems for software-enabled medical devices.
Own CAPA activities, software validation, and risk management throughout the product lifecycle.
Lead design verification and validation testing alongside engineering teams.
Oversee SOUP and COTS software validation and collaborate with regulatory consultants and the FDA.
Manage vendor quality and supplier performance to ensure compliance and product integrity.

What My Client Is Looking For

SaMD experience is a must. I hate to be a stickler, but this is the only part I need to emphasize.
A strong understanding of software-related quality systems, medical device compliance, and risk management.
Compliance with ISO 13485, ISO 14971, and IEC 62304 is required. Being well-versed in regulatory frameworks for medical software and device quality management is crucial for them
Experience with medical imaging systems or software-enabled devices.
A strong understanding of software-related quality systems, medical device compliance, and risk management.

Bonus Points If You Have

Familiarity with regulatory submissions and approvals.
Exposure to IEC 60601 (hardware compliance) is a plus but not required.
Startups are a different beast of company. If you're comfortable in ambiguity and flying by the seat of your pants, it might be for you.

This role is ideal for someone who wants more than just a job (although yes, it'll be nice to you know, pay bills and put food on the table. My client won't ever be arrogant enough to ask, "tell me why you want to work here")—it’s a chance to shape quality processes at the ground floor in a growing startup while having the security of being backed by a public company.

If you made it this far, you either (a) might actually be interested or (b) just enjoy reading job ads for fun. I do the same on Zillow looking at mansions I can't afford yet. But if I place you, I'll be one fee closer to a deposit.

In any case, fire over your CV and I'll genuinely try to get something on the books with you as this is an urgent hire.

I promise you I'm a delight to work with.

Senior Software Quality Engineer (SaMD)