Product Development Engineer

Biodevek; Cambridge (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

BioDevek, a pioneering medical device startup, seeks a hands-on Medical Device Design Engineer for their innovative team. The role involves leading the mechanical design and prototyping of a sprayable hydrogel device to manage gastrointestinal bleeding. Ideal candidates will have solid experience in medical device product development and strong CAD skills, contributing to impactful patient outcomes as the product approaches regulatory submission.

Qualifications

• 5+ years of medical device product development experience.
• Strong knowledge of FDA and ISO standards.
• Experience with catheter-based delivery systems is a plus.

Responsibilities

• Design and develop components for the endoscopic delivery system.
• Execute benchtop testing and usability assessments.
• Collaborate with CROs and CMO for design iteration.

Skills

Proficiency in CAD software

Communication skills

Project management skills

Hands-on prototyping

Usability testing

Education

Bachelor's or Master's in Engineering

Job description

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BioDevek is a pioneering medical device startup developing biomaterial-based solutions for hemostasis in endoscopic and minimally invasive procedures. Our lead product is a sprayable, biocompatible hydrogel designed to rapidly and safely control gastrointestinal bleeding and protect internal wounds.

We are advancing quickly toward our first regulatory submission, with the goal of bringing this novel technology to the clinic. Joining BioDevek offers a unique opportunity to lead the development of a transformative medical device and make a direct impact on patient outcomes.

Role Description

We are seeking a hands-on Medical Device Design Engineer to lead the mechanical design, prototyping, and early-stage testing of our endoscopic delivery system. You will work closely with our internal team and external engineering and manufacturing partners to translate design requirements into functional, testable prototypes. This is a high-impact, execution-focused role ideal for an engineer who thrives in a fast-paced, startup environment and enjoys building things that matter.

Key Responsibilities

• Design and develop components for handheld catheter-based delivery system using CAD tools (e.g., SolidWorks)
• Rapidly iterate on physical prototypes using in-house tools and external fabrication vendors
• Execute benchtop testing, usability assessments, and verification experiments
• Translate clinical and user needs into engineering specifications and design inputs
• Collaborate with contract research organizations (CROs) and manufacturers (CMOs) to support design iteration and device refinement
• Participate in design control activities, including risk management (FMEA), design verification, and documentation under ISO 13485 and 21 CFR Part 820
• Support preparation of technical documentation for regulatory submissions (e.g., 510(k))

Experience

• 5+ years of experience in product development within the medical device industry, ideally with a focus on catheters, endoscopic delivery systems, or related technologies.
• Proven track record working within design control frameworks, including risk management, design verification/validation, and regulatory documentation.
• Strong working knowledge of FDA and ISO standards (e.g., ISO 13485, 21 CFR Part 820).
• Proficiency in CAD software (e.g., SolidWorks) and hands-on experience with rapid prototyping and benchtop testing is a plus.
• Familiarity with 510(k) submissions and regulatory pathways for Class II devices is a strong plus.
• Excellent communication and project management skills, with the ability to coordinate across technical, quality, and external teams.
• Comfortable operating in an early-stage, hands-on environment with evolving priorities and limited structure.

Please note: We are not working with recruiters or agencies for this role. Unsolicited outreach will not be considered.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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