Highly Experienced Medical Equipment Design Engineer

JOB TITLE: Principal Mechanical Engineer / Engineering Lead — Medical Devices (US Client, Long-Term)
Job Type: Contract / Project-based, Full-time hours
Work Setup: 100% Home-based / Remote
Pay: Competitive Compensation; Commensurate with experience
Work Hours: US Mountain Time business hours (required, you'll be working the same schedule as the US team, not night shift)

About the company
We are a well-established, Colorado-based medical device engineering company. We help clients design and build Class II medical devices, everything from early concept through prototyping and testing to final design. This is a long-term opportunity with a stable, growing US company that genuinely values senior-level Filipino engineering talent; this isn't a one-off gig.

About the Role
We are looking for an experienced Medical Equipment Design Engineer to take the lead on their engineering projects. You'll do real, hands-on engineering work; SolidWorks CAD, FEA simulations, GD&T drawings—while also being the senior technical contact for their US-based clients and guiding a small team of 1 to 5 engineers depending on what's active. This is a senior, high-responsibility role, and it's fully remote, working US Mountain Time business hours.

What You'll Be Doing
● Lead the technical/mechanical engineering side of Class II medical device projects.
● Do hands-on work yourself: SolidWorks CAD modeling, assembly design, FEA (structural, thermal, fatigue), tolerance analysis, and GD&T drawings (ASME Y14.5).
● Be the main point of contact for clients on technical questions—running design reviews and status updates directly.
● Handle the engineering side of project management—scoping, timelines, tracking progress, and flagging risks early.
● Lead and mentor a small team of 1–5 engineers.
● Take projects from concept to final design, prototyping, testing, and handoff—following proper design controls.
● Build and test prototypes hands-on when needed (3D printing, machining, bench testing).
● Review and approve engineering documents (drawings, specs, test protocols) before they go to the client.

What You Need to Qualify
● At least 10 years of experience in medical device engineering (mechanical engineering focus).
● Direct experience with Class II medical devices—design controls, ISO 14971 risk management, design history files.
● Strong, hands-on SolidWorks skills—you should be very comfortable modeling and creating drawings yourself.
● Solid experience running FEA in SolidWorks Simulation.
● Strong GD&T knowledge (ASME Y14.5) and experience with tolerance stack-up analysis.
● Understanding of DFM/DFA for manufacturing (injection molding, machining, sheet metal) and material selection
(including biocompatibility).
● Basic electrical engineering knowledge is a plus.
● Experience managing engineering projects—timelines, scope, tracking.
● Strong English communication skills—you'll be speaking directly with US clients.
● Experience leading or mentoring a small engineering team.
● Able to work US Mountain Time business hours.

Nice to Have
● PMP certification
● Background in consulting or professional services
● Knowledge of FDA 510(k) submissions and ISO 13485

Why Work With Us
● Long-term, stable contract, not a short gig.
● Work directly with a US-based company that respects and values remote Filipino talent.
● A genuinely senior role, real ownership, real trust, real say in the engineering work.
● 100% remote, work from home.

How to Apply
Send your updated resume/CV to ---------- your application, please include a short summary of your SolidWorks and medical device experience so we can review your background quickly. We'll reach out directly if you're a good fit.