Medical Device Engineer
1 month ago
Cresilon, Inc. is a biotechnology company that develops and markets hemostatic medical devices utilizing proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure.
Key Responsibilities:
- Lead the design and development of new products and improve existing products with compliance with all quality and regulatory requirements.
- Author technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards.
- Provide project-specific support, including technical analysis and review of supplier documentation as required.
- Develop and execute test methods to aid in exploratory research, product development, and quality control.
- Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities.
Requirements:
- BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline with 4+ years of product development experience.
- A minimum of 2 years of hands-on experience in new product research and development in a cGMP-regulated industry.
- Adept experimentalist with hands-on experience in product development of polymeric medical devices and their safety/efficacy characterization in an R&D environment.
- Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans.
Benefits:
- Competitive annual base salary range of $60,000 - $160,000, depending upon job level and qualifications.
- Paid Vacation, Sick, & Holidays.
- Monthly MetroCard Reimbursement.
- 401(k) & Roth Retirement Savings Plan with company match up to 5%.
- Work/Life Employee Assistance Program.
- Company Paid Life and Short-Term Disability Coverage.
- Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage.
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