FDE Systems Engineer - MedTech New HQ

SynthBee, Inc.; Town of Florida, Northern (NY, KY); Vor Ort; USD 150.000 - 220.000; Vollzeit

Zusammenfassung

SynthBee, Inc. in Pembroke Pines, FL, seeks an FDE Systems Engineer with MedTech CAD focus to bridge advanced automation with medical standards. You will shape end‑to‑end mechanical and electromechanical systems for surgical tools, diagnostics, and wearables.

The role emphasizes 3D modeling, GD&T, and tolerance stack‑ups, with CAD experience in SolidWorks/CATIA. You’ll lead rapid prototyping, inform manufacturing readiness, and ensure compliance with ISO 13485 and FDA guidelines.

Qualifikationen

• 10-15+ years hands-on mechanical design experience in MedTech.
• Experience bringing physical products to market in MedTech.
• Advising on hardware integration with ISO/IEC safety frameworks.
• Prototyping using SLA/SLS and vacuum casting.
• Expert in 3D CAD tools (SolidWorks, CATIA).

Aufgaben

• End-to-End Product Development: design and engineer mechanical and electromechanical systems for medtech and healthcare applications.
• Mechanical Engineering & PLC Alignment: 3D modeling, 2D schematics, GD&T, and tolerance analysis across PLC.
• Rapid Prototyping & Testing: lead prototyping cycles using in-house 3D printing and external vendors; define benchtop tests.
• DFM & Value Engineering: prepare for manufacturing; apply cost-reduction while maintaining quality.
• Regulatory Compliance: identify design-cycle requirements for medical device regulations; support DHF, FMEA, V&V.
• Cross-Functional Leadership: translate user needs into actionable explanations for partnered engineers.

Kenntnisse

3D modeling

GD&T

Tolerance analysis

Regulatory awareness

Prototyping planning

Cross-functional collaboration

Problem solving

Ausbildung

Bachelor’s or Master’s in Mechanical or Biomedical Engineering

Tools

SolidWorks

CATIA

Jobbeschreibung

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.

Not sure you check every box? Apply anyway. 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.