Senior Design Engineer
: Job Details :

BioDevek is a pioneering medical device startup developing innovative biomaterial solutions to improve surgical outcomes. Our primary focus is on bleeding control during endoscopy and other minimally invasive procedures. Our unique platform technology is designed to quickly, safely, and effectively control bleeding and protect wounds with a simple spray of biocompatible hydrogel. Our top priority is to advance quickly toward our first regulatory submission to bring this technology to the clinic and improve patient outcomes. Joining BioDevek offers an exceptional opportunity to lead the development of our medical device and shape the future of our impact in the medical field.

Role Description

We are seeking a Senior Product Design Engineer to lead the technical development of our biomaterial-based medical device. This role will focus on prototype design, design control, and ensuring quality and compliance throughout the development process. You will be responsible for overseeing the design and engineering of the device, working closely with internal teams, and managing external partners, including contract research organizations (CROs), to drive the project forward. This position requires a hands-on approach to engineering and a deep understanding of regulatory requirements, with an emphasis on delivering a high-quality, effective product to market.

Key Responsibilities:

• Lead the design, prototyping, and development of the biomaterial-based delivery system.
• Ensure product quality and regulatory compliance in alignment with FDA and ISO standards throughout the development cycle.
• Oversee the full product lifecycle, from initial concept and prototyping through to testing and production readiness.
• Develop and document detailed product specifications and testing procedures, ensuring they meet industry standards for quality and performance.
• Collaborate closely with Quality and Regulatory teams to align product design with required standards and manage risk analysis (e.g., FMEA).
• Manage relationships with contract research organizations (CROs) and other external partners, ensuring project timelines and quality standards are met.
• Support design verification and validation, including creating and executing protocols and coordinating testing activities.

Requirements:

• Minimum of 5 years of experience in product development within the medical device industry, with a focus on delivery systems, catheters, or related technologies.
• Experience with 510(k) submission processes, including documentation and compliance requirements, is a strong plus.
• Strong working knowledge of FDA and ISO regulatory standards for design control (ISO 13485, 21 CFR Part 820).
• Proficiency in CAD software (e.g., SolidWorks) and experience with prototyping techniques.
• Practical experience with risk management and quality processes, including FMEA, DFMEA, and root cause analysis.
• Exceptional problem-solving skills, attention to detail, and the ability to thrive in a fast-paced startup environment.
• Demonstrated ability to work independently and collaboratively within a small team.

BioDevek is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.