FDE Systems Engineer - MedTech

SynthBee, Inc.; Florida; On-site; USD 120,000 - 180,000; Full time

Job summary

SynthBee, Inc. is seeking an FDE Systems Engineer focused on MedTech CAD design. You will bridge agentic technologies with rigorous medical device standards, driving end-to-end mechanical development for surgical tools, diagnostic equipment, and wearables.

Ideal candidates have 10–15+ years of hands-on MedTech design experience, strong 3D CAD skills (SolidWorks/CATIA), and a track record in DFM, V&V, and regulatory documentation. This is an in-person role at the Pembroke Pines, FL HQ.

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 10–15+ years of hands-on mechanical design experience within MedTech.
• Experience with medical devices, design history files, and risk management is preferred.

Responsibilities

• Conceptualize, design, and engineer mechanical and electromechanical MedTech systems.
• Lead rapid prototyping cycles using in-house 3D printing and external vendors.
• Align mechanical design with PLC, GD&T, tolerance stack‑ups, and interfaces.
• Collaborate with Electrical and Software teams to integrate devices into regulated apps.
• Support Design for Manufacturability and value engineering initiatives.

Skills

3D CAD

SolidWorks

CATIA

GD&T

Regulatory know-how

Prototyping

Cross-functional leadership

Manufacturing liaison

Education

Bachelors/Masters in Mechanical/Biomedical Eng

Tools

3D Printing

SLA/SLS

CNC Machining

Injection Molding

PLM software

Job description

ABOUT SYNTHBEE

SynthBee was founded to build safe, scalable, and reliable Collaborative Intelligence™ to amplify human innovation. We apply our novel computing intelligence platform to complex, mission-critical systems across healthcare, defense, aerospace, automotive, robotics, security, climate, and more—for customers who demand reliability, transparency, and ethics above all.

ABOUT THE ROLE

As an FDE Systems Engineer - MedTech focused in CAD Design, you will act as the primary link between SynthBee’s agentic technologies and the rigorous geometric and engineering standards of our MedTech partners.

WHAT YOU’LL DO

• End-to-End Product Development: Conceptualize, design, and engineer mechanical and electromechanical systems for medtech and healthcare applications (e.g., surgical tools, diagnostic equipment, wearable therapeutics, and drug delivery systems).
• Mechanical Engineering & PLC Alignment: Strong comprehension of 3D modeling, detailed 2D schematics, GD&T, and tolerance stack-ups to effectively evaluate mechanical interface requirements across the Product Life Cycle (PLC). Prior CAD experience (SolidWorks or CATIA) is preferred but not required.
• Rapid Prototyping & Testing: Lead iterative prototyping cycles using in-house 3D printing, machining, and external vendor capabilities. Define benchtop testing to validate mechanical performance.
• Design for Manufacturability (DFM) & Value Engineering: Communicate design review requirements to prepare for manufacturing (e.g., injection molding, machining, stamping). Apply value engineering principles to reduce product costs while maximizing utility, quality, scalability, and user experience.
• Regulatory Compliance: Identify requirements to incorporate in design cycle processes to meet medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820). Familiarity with Design History Files (DHF), risk management (FMEA), and verification/validation (V&V) documentation to support the Design Cycle.
• Cross-Functional Leadership: Act as the technical voice in the room. Translate complex needs and user-research insights into collaborative explanations for partnered engineers to feel confident in defending their design decisions and the robustness of our systems.

Soft Skills: High tolerance for ambiguity, exceptional problem-solving abilities, and the communication skills required to articulate technical trade-offs to non-technical business leaders.

WHAT YOU’LL BRING

• Education: Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a closely related discipline.
• Experience: 10-15+ years of hands-on mechanical design experience, with a proven track record of bringing physical products to market specifically within the MedTech industry.
• Human Factors Engineering: Providing strategic advisory on the integration of complex medical systems, delivering recommendations that optimize hardware architecture for seamless, hands-free operation within diverse clinical environments in alignment with ISO and IEC safety frameworks.
• Smart Systems Integration: Proven track record of collaborating with Electrical and Software teams to integrate devices into highly regulated applications and use cases. (EX: embedded sensors, wireless modules (BLE/Wi-Fi), and power management into compact mechanical architectures.
• Prototyping Agility: Proficiency in sophisticated rapid-prototyping techniques, such as SLA/SLS 3D printing for functional testing or vacuum casting for bridge production.
• Mechanical Engineering & PLC Alignment: Strong comprehension of 3D modeling, detailed 2D schematics, GD&T, and tolerance stack-ups to effectively evaluate mechanical interface requirements across the Product Life Cycle (PLC). Prior CAD experience (SolidWorks or CATIA) is preferred but not required.
• Expert-level skills in 3D CAD software - SolidWorks, CATIA .
• Deep understanding of manufacturing processes, particularly plastic injection molding, CNC machining, sheet metal fabrication, and assembly methods.

At SynthBee, we value unique perspectives, transferable skills, and a genuine growth mindset. If this work excites you and your experience aligns with the core responsibilities, we want to hear from you.

YOU SHOULD APPLY IF

You love solving problems that don’t have textbook answers. You build as naturally as you think, and you want your work to matter—for people, for the planet, for the future of intelligence. You’re creative, imaginative, and deeply ethical. You believe in decency and collaboration. You are not here to follow the crowd.

WORKING CONDITIONS

This is a full-time, in-person role at SynthBee HQ in Pembroke Pines, FL, Monday through Friday. The role requires extended periods of computer use, research, and code development. Our office is a dynamic, high-energy environment built for the kind of deep collaboration and creative problem-solving that thrives in person. Reasonable accommodations will be provided in accordance with the ADA. Please refer to the BeeKeeper’s Guide for details.

OUR COMMITMENT TO YOU

SynthBee is proud to be an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local law. We offer competitive compensation, comprehensive benefits, and generous paid time off.