Product Development Engineer

BioDevek; Cambridge (MA); On-site; USD 100,000 - 125,000; Full time

Job summary

Ein innovatives Unternehmen im Bereich Medizintechnik sucht einen engagierten Medical Device Design Engineer. In dieser Rolle haben Sie die Möglichkeit, die Entwicklung eines bahnbrechenden medizinischen Geräts zu leiten, das sich auf die Kontrolle von gastrointestinalen Blutungen konzentriert. Sie arbeiten eng mit internen Teams und externen Partnern zusammen, um funktionale Prototypen zu erstellen und klinische Anforderungen in technische Spezifikationen zu übersetzen. Wenn Sie in einem dynamischen Umfeld arbeiten möchten, in dem Ihre Beiträge direkte Auswirkungen auf die Patientenversorgung haben, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• 5+ Jahre Erfahrung in der Produktentwicklung im Bereich Medizintechnik.
• Erfahrung mit Designkontrollrahmen und Risikomanagement.

Responsibilities

• Entwicklung von Komponenten für katheterbasierte Liefersysteme mit CAD-Tools.
• Durchführung von Benchtop-Tests und Usability-Bewertungen.

Skills

Produktentwicklung

CAD-Software (SolidWorks)

Regulatory Documentation

Kommunikationsfähigkeiten

Projektmanagement

Education

Bachelor in Ingenieurwissenschaften

Master in Ingenieurwissenschaften

Tools

SolidWorks

Rapid Prototyping Tools

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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