Work from Home Principal Mechanical Engineer (Medical Devices) — Remote, Contract, US Mountain Time Jobs, in Kruew - Maukerja

About the Job

We're a Colorado-based medical device engineering firm that helps clients design and develop Class II medical devices — from concept through prototyping, testing, and design transfer. We're hiring a Principal Mechanical Engineer / Engineering Lead to own technical delivery across our project portfolio. This is a hands-on role: you'll do real engineering work yourself (SolidWorks CAD, FEA, GD&T drawings) while also being the senior technical voice for our clients and leading a small team of 1–5 engineers as needed. We're specifically looking for skilled, working US Mountain Time business hours.

Responsibilities

Lead the technical side of Class II medical device projects — primarily mechanical engineering, with some electrical engineering overlap.

Perform hands-on engineering work: SolidWorks CAD modeling and assembly design, FEA (structural, thermal, fatigue as needed), tolerance analysis, and GD&T drawings per ASME Y14.5.

Serve as the main technical contact for clients, running design reviews and engineering decisions directly with their team.

Manage the engineering side of projects — scoping tasks, setting timelines, tracking milestones, and flagging risks.

Lead and mentor a team of 1–5 engineers, assigning work based on project needs.

Guide projects from concept through detailed design, prototyping, verification, and design transfer, following design controls and regulatory requirements.

Build and test prototypes hands-on (3D printing, machining, bench testing, troubleshooting).

Review and approve engineering deliverables (drawings, specs, DFMEAs, test protocols) before they go to clients.

Spot technical risks early and bring solutions to the team and clients.

Requirements

10+ years of medical device engineering experience, with mechanical engineering as your primary discipline.

Direct experience with Class II medical devices: design controls, risk management (ISO 14971), design history files.

Strong hands-on SolidWorks skills (3D modeling, assemblies, drawings).

Experience running SolidWorks Simulation FEA (structural, thermal, and/or fatigue).

Strong GD&T knowledge (ASME Y14.5) — able to create manufacturing-ready drawings and run tolerance stack-up analysis.

Working knowledge of DFM/DFA for medical device manufacturing (injection molding, machining, sheet metal) and biocompatible materials (ISO 10993).

Basic electrical engineering knowledge, enough to collaborate with or guide EE-focused work.

Proven project management experience — scoping, scheduling, tracking.

Strong communication skills, comfortable with both technical and non-technical stakeholders.

Experience leading or mentoring engineers.

Nice to Have

PMP certification

Consulting or professional services background

Familiarity with FDA 510(k) and ISO 13485

Exposure to human factors/usability engineering and sterilization (EtO, gamma)

Benefits / What We Offer

Fully remote work

Long-term contract with a stable, established US-based company.

Meaningful, senior-level ownership on real medical device projects.

Flexibility to lead a small team while staying hands-on with the engineering work you enjoy.

How to Apply

Click Apply on this listing. Please include a short note on your SolidWorks and medical device experience.

Benefits:

• Additional leave
• Work from home

Application Question(s):

• How many years of professional mechanical engineering experience in medical device development do you have?
• Do you have hands-on experience with medical device design controls, risk management (ISO 14971), and Design History Files (DHF)? If yes, please briefly describe your experience, including the types of Class II medical devices you worked on and your specific responsibilities.
• Are you able to work U.S. Mountain Time business hours on a consistent basis?

Experience:

• SolidWorks: 10 years (Required)

Work Location: Remote