We are seeking a Hybrid Mechanical Engineer to join an innovative and lean startup developing cutting-edge high-frequency energy-based solutions for medical applications. This position is ideal for a hands-on, resourceful engineer with a background in medical device design who thrives in a fast-paced, collaborative environment.

Key Responsibilities:

• Product Design:
• Develop and design hardware for system components, ensuring adherence to stringent medical device standards.
• Write and refine detailed product requirements, conduct design analysis, and perform failure mode analysis.
• Execute verification testing and provide solutions to complex, constrained design challenges.
• Prototyping and Testing:
• Build prototypes, support clinical and bench testing, and implement process improvements.
• Collaborate with vendors and subject-matter experts to optimize product functionality and manufacturability.
• Cross-Functional Collaboration:
• Work closely with system engineers, electrical engineers, clinicians, and regulatory teams.
• Coordinate with outside suppliers to manage requirements and maintain timelines.
• Documentation:
• Develop Design History File (DHF) deliverables, including test protocols, design inputs, and risk analyses.
• Support FDA Design Control processes and ensure compliance with Quality Systems.

Qualifications:

Experience:

• 5-7+ years of product design and development in the medical device industry .
• Proven expertise in new product introduction, including requirement writing, supplier management, and verification testing.

Technical Skills:

• Proficient in SolidWorks (approx. 20% CAD usage).
• Knowledge of FDA Quality Systems and Design Control Processes.
• Familiarity with plastic molding and 3D printing (preferred).

Soft Skills:

• Highly resourceful and self-driven, capable of managing projects and external vendor relationships.
• Effective collaboration skills with cross-functional teams and external stakeholders.
• Strong problem-solving abilities for highly constrained design challenges.

What We Offer:

• Mission-Driven Work: Be part of a team addressing a significant medical need with innovative solutions.
• Growth Opportunity: Play a pivotal role in the FDA approval and market launch of a revolutionary product within 2-3 years.
• Financial Upside: Competitive salary ($110,000–$150,000 based on experience) and stock options with high potential for returns.
• Comprehensive Benefits:
• 80% employer-paid health insurance for employees (60% for dependents).
• 3-4 weeks of vacation plus up to 20 sick days banked separately.
• 10 paid holidays annually.
• Hybrid Work Environment: On-site 3 days a week (Monday, Wednesday, Thursday)