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Hiring: Product Development Engineer – Medical Device Startup
Location: Flexible (Remote/Hybrid with travel as required)
We are seeking an experienced Lead Product Development Engineer to join an exciting early-stage medical device venture built around a patented innovation with the potential to improve patient care.
This is a unique opportunity to lead the technical development of a novel medical device from patented concept through prototype, product validation, manufacturing readiness, and investor presentation.
Key Responsibilities
- Lead end-to-end development of a patented medical device.
- Transform the patented concept into a functional, manufacturable product.
- Develop CAD models, engineering drawings, and technical documentation.
- Build and manage prototypes through multiple design iterations.
- Apply Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.
- Conduct engineering analysis, testing, verification, and validation.
- Collaborate with industrial designers, electronics engineers, manufacturers, and regulatory consultants.
- Develop manufacturing strategies, supplier relationships, and production plans.
- Prepare technical documentation aligned with FDA Design Controls and ISO 13485 requirements.
- Support intellectual property strategy while maintaining strict confidentiality.
- Create compelling product demonstrations and technical materials for venture capital firms and angel investors.
- Participate in investor meetings by explaining the technology, product roadmap, development milestones, and commercialization strategy.
Required Qualifications
- Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Product Design Engineering, or a related field.
- 3+ years of experience in medical device product development.
- Proven experience taking a medical device from concept to prototype and ideally through commercialization (preferable))
- Expert proficiency with SolidWorks or comparable 3D CAD software.
- Strong knowledge of prototyping methods, materials, and manufacturing processes.
- Excellent project management and communication skills.
- Ability to work independently in a fast-paced startup environment.
Preferred Qualifications
- Previous experience in a MedTech startup.
- Experience supporting fundraising efforts or presenting technical products to investors.
- Established network of manufacturers, prototyping vendors, and engineering partners.
- Experience with product cost optimization and manufacturing scale-up.
- Knowledge of quality systems and regulatory submissions.
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