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Cresilon

Plant-based hemostatic gel for bleeding control

Senior Medical Device Research and Development Engineer

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeBrooklyn, NY, USA$100k - $160k /yr

About the Job

Requirements

  • A Bachelor of Science in Chemical Engineering, Polymer Engineering, Materials Science, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline is required.
  • At least 5 years of product development experience is required.
  • At least 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required; medical device experience is strongly preferred.
  • Hands-on experience developing medical devices and characterizing their safety and efficacy in an R&D environment is required.
  • Experience gathering user needs, translating them into technical inputs, and developing viable design verification and validation plans is required.
  • Experience leading complex product development initiatives from concept through product launch or release is required.
  • Working knowledge of anatomy and surgical procedures is required.
  • Ability to solve difficult technical problems and deliver practical solutions that meet application requirements, using analytical, problem-solving, decision-making, observational, and creative skills, is required.
  • Ability to design experiments and analyze data using appropriate quality and statistical methodologies is required.
  • Ability to work independently, contribute effectively to a team, and work cross-functionally to expedite critical project tasks is required.
  • Ability to handle multiple medium-scope and medium-complexity project assignments, prioritize, and complete work promptly is required.
  • Ability to lead directly and by influence, including problem-solving, conflict resolution, and analytical skills, is required.
  • Strong leadership, written and verbal communication, and presentation skills are required.
  • Working knowledge of FDA requirements under 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007 is required.
  • Working knowledge of Good Documentation Practices and current Good Manufacturing Practices is required.
  • Understanding of statistical tools and validation and verification techniques is required.
  • Proficiency in Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required.
  • Legal authorization to work in the United States is required.
  • An advanced degree, either a Master of Science or Ph.D., is strongly preferred.
  • Six Sigma green belt or black belt certification is preferred.

Responsibilities

  • Create and lead experiments for exploratory and product-development research focused on polymeric materials devices and their use.
  • Define new-product functional requirements, including design inputs and user needs, and evaluate designs for effectiveness, cost, reliability, and safety.
  • Lead cross-functional teams developing new products, addressing design issues, and maintaining existing designs.
  • Work independently to plan and schedule activities needed to meet project timelines.
  • Work with quality, manufacturing, regulatory, clinical, and marketing teams to ensure project success.
  • Lead creation of design history file documentation throughout the new-product development process.
  • Develop new implant and instrument designs using SolidWorks and modeling and detailed design specifications.
  • Generate technical protocols and reports supporting device safety and efficacy.
  • Create concepts and designs and submit invention disclosures.
  • Ensure design activities comply with FDA Quality System Regulations and ISO 13485 design control and risk management requirements; lead material, design, and process changes through design control with documented research and analyses.
  • Author protocols and reports for development studies and design verification and validation activities.
  • Develop and execute test methods for exploratory research, product development, and quality control; conduct chemical and mechanical property tests to evaluate process or formulation changes.
  • Apply technical judgment in designing, executing, and interpreting experiments and use scientific methods and procedures to solve complex problems creatively and effectively.
  • Prepare samples for testing or other evaluations and perform data analysis, including in voice-of-customer laboratories.
  • Work with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication.
  • Maintain a laboratory notebook and technical documentation in accordance with required Good Laboratory Practice and Good Manufacturing Practice guidelines.
  • Maintain active dialogue with Regulatory Affairs as a subject-matter expert on product design elements and documentation for research supporting FDA or other regulated-authority submissions.
  • Support marketing and sales and introduce new technologies by developing presentations, sales tools, formulations, and application data.
  • Communicate results to the scientific community through published papers and present research at academic and industry symposia as an external company representative.
  • Manage part-time staff as a research leader and mentor for ongoing research projects.
  • Work with company leadership to evaluate existing research practices and contribute to ethical, high-quality research operations.
  • Provide other project or product support as needed to support company business objectives.
  • Perform other duties as assigned and required.

Desired Qualifications

  • Medical device field experience is strongly preferred.
  • Hands-on product-development experience with Class II and Class III medical devices is preferred.
  • Experience developing test methods and protocols or reports for safety and efficacy testing of implant and instrument designs is preferred.
  • Experience with IDE and PMA submissions is preferred.

About the Company

Cresilon

Plant-based hemostatic gel for bleeding control

Cresilon makes medical devices that stop bleeding with a plant-based adhesive gel. Its main product, VETIGEL, is a fast-acting gel designed to control bleeding in veterinary patients, and Cresilon serves human trauma and surgical markets as well. The gel is applied to a wound and works to seal and promote clotting within seconds without needing manual pressure. Cresilon differentiates itself by offering a gel-based hemostat and by being among the first to target veterinary applications with a rapid, easy-to-use solution, along with direct sales and partnerships (for example, the VerticalVet Preferred Partnership) to reach clinics and hospitals. The company’s goal is to broaden the gel technology’s uses to improve wound care and save lives across veterinary, human trauma, and surgical settings.

Company size
51-200
Company stage
Early VC
Total funding
$116.5M
Headquarters
New York City, New York
Founded
2010

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