Research and Development Senior Medical Device Engineer
Not Disclosed•Full-TimeOn-site
location_on468, 6th Avenue, Park Slope, Brooklyn, Kings County, New York, 11215, United States
About Cresilon
Cresilon is a Brooklyn-based biotechnology company dedicated to revolutionizing the standard of care for traumatic and surgical bleeds. Utilizing proprietary plant-based hydrogel technology, the company develops, manufactures, and markets hemostatic medical devices that stop bleeding in seconds without the need for extended manual pressure. With a mission to save lives, Cresilon's current and future product lines target veterinary, human trauma, and human surgical applications. Learn more at www.cresilon.com.
About the Role
The Senior Medical Device Engineer serves as a pivotal leader in the design and development of new products and the enhancement of existing ones. This role is designed for a hands-on experimentalist who aspires for excellence and possesses a bias toward action. You will roll up your sleeves to drive projects forward in a fast-paced environment, partnering with customers to create best-in-class products that dominate the marketplace.
In this multi-faceted position, you will work within a highly collaborative, multidisciplinary team of researchers. The role demands flexibility and a commitment to exploring new technologies and techniques to ensure product innovation and robustness. You will be responsible for the full lifecycle of product development, from defining functional requirements and leading cross-functional teams to authoring technical documents and ensuring compliance with rigorous quality and regulatory standards. This is a full-time, on-site position located in Brooklyn, New York, and is not an entry-level role.
Hiring Process
- Initial Review: Applications are reviewed based on qualifications, merit, and business needs.
- Interview Stages: Candidates will engage in a series of interviews designed to assess technical expertise, problem-solving capabilities, and cultural fit within our collaborative environment.
- Final Decision: Hiring decisions are made based on the candidate's ability to solve complex technical problems and contribute to Cresilon's mission.
Equal Opportunity Employer
Cresilon is an equal-opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Similar Job Opportunities
Skills, education and keywords
Skills: Solidworks, Microsoft Excel, Microsoft Word, Microsoft Powerpoint, Six-Sigma Green Belt, Six-Sigma Black Belt, 21 CFR 820, Iso 9001, Iso 13485:2003, Iso 14971:2007.
Education: Advanced degree (MS or Ph.D.) strongly preferred.
Frequently asked questions about Research and Development Senior Medical Device Engineer at Cresilon
What does a Research and Development Senior Medical Device Engineer at Cresilon do?expand_more
Day-to-day, the Research and Development Senior Medical Device Engineer at Cresilon will lead experimentation for exploratory and product development research focusing on polymeric materials devices; define new product functional requirements and evaluate design effectiveness, cost, reliability, and safety; lead cross-functional teams to develop new products, address design issues, and maintain existing designs; and develop new implant and instrument designs utilizing solidworks and modeling/detail design specifications.
What are the requirements for this Research and Development Senior Medical Device Engineer role?expand_more
Cresilon is looking for candidates who meet the following requirements: BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline; 5+ years of product development experience; 4+ years of hands-on experience in new product R&D in a cGMP-regulated industry; Good working knowledge of anatomy and surgical procedures; Working knowledge of FDA requirements (21 CFR 820, ISO 9001, ISO 13485:2003, ISO 14971:2007); and Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).