Research and Development Medical Device Engineer - Cresilon : Job Details

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Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing proprietary hydrogel technology. The company's innovative plant-based technology stops traumatic and surgical bleeds in seconds without manual pressure. Its product lines target veterinary, human trauma, and surgical applications. Cresilon's mission is to save lives. Learn more at www.cresilon.com.

The Medical Device Engineer will lead design and development of new products and improve existing ones, ensuring compliance with quality and regulatory standards. Responsibilities include authoring technical documents, supporting project-specific activities, and conducting formulation development, performance characterization, and prototype fabrication. The role demands a hands-on approach, a bias for action, and collaboration with multidisciplinary teams to drive innovation and product robustness.

• Lead experimentation on polymeric materials and device development.
• Define product requirements and evaluate design effectiveness, reliability, and safety.
• Manage cross-functional teams to develop and maintain products.
• Apply problem-solving skills to complex technical issues.
• Plan and execute activities independently to meet project timelines.
• Collaborate with quality, manufacturing, regulatory, clinical, and marketing teams.
• Create design history files and technical documentation.
• Design implant and instrument components using SolidWorks.
• Develop protocols and reports to support device safety and efficacy.
• Innovate and submit invention disclosures.
• Ensure adherence to FDA and ISO standards, managing design changes accordingly.
• Author development protocols and validation reports.
• Develop and perform test methods for research and quality control.
• Design and analyze experiments, maintaining proper documentation.
• Interface with customers and suppliers for specifications and prototypes.
• Maintain technical records per GLP/GMP guidelines.
• Support regulatory documentation and communicate with regulatory affairs.
• Assist marketing with technical presentations and applications data.
• Publish research findings and present at industry forums.
• Lead and mentor research staff.
• Contribute to ethical research practices and organizational culture.
• Provide additional project support as needed.

• BS in relevant engineering/science disciplines.
• 4+ years in product development, with 2+ years in cGMP-regulated medical device R&D.
• Hands-on experience in medical device research, safety, and efficacy testing.
• Experience translating user needs into technical plans and leading complex projects.
• Knowledge of anatomy and surgical procedures.
• Strong analytical and problem-solving skills.
• Ability to design experiments, analyze data, and work independently and collaboratively.
• Excellent communication and leadership skills.
• Knowledge of FDA 21 CFR 820 requirements.
• Proficiency in MS Office Suite.
• Legal authorization to work in the U.S.

• Advanced degrees (MS or Ph.D.).
• Experience with polymeric materials and test method development.
• Knowledge of ISO 9001, ISO 13485, ISO 14971, and regulatory submissions.
• Six Sigma certification.

Cresilon is an equal-opportunity employer committed to diversity and inclusion, prohibiting discrimination based on protected characteristics. We base hiring decisions on qualifications, merit, and business needs.

• Salary range: $80,000 - $160,000, depending on experience.
• Paid time off, holidays, and monthly MetroCard reimbursement.
• 401(k) with company match, health benefits, and more.