Cresilon, Inc.

Cresilon, Inc.

Senior Medical Device Research and Development Engineer

Brooklyn, New York, United States · Senior · Part-time

Sponsorship not specified$100k-$160kDetected 44 days ago
Data AnalysisA/B TestingSalesExcelSolidWorksMechanical DesignGMPFDA RegulatoryMedical DevicesResearchLeadershipCommunicationProblem SolvingPublic SpeakingMicrosoft OfficeRegulatory Affairs

About the role

  • 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.
  • The company's current and future product lines target veterinary, human trauma, and human surgical applications.
  • Learn more about the company at www.cresilon.com.

Responsibilities

  • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use.
  • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety.
  • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs.
  • Work independently to plan and schedule own activities necessary to meet project timelines.
  • Lead the creation of design history file documentation through the new product development process.
  • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications.
  • Generate technical protocols/reports to support device safety and efficacy.
  • Invent/create concepts and designs and submit invention disclosures.
  • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements.
  • Lead material/design/process changes through a design control process, with well-documented research/analyses.

Requirements

  • A minimum of 5+ years of product development experience is required.
  • Experience leading complex product development initiatives from concept through product launch/release.
  • Good working knowledge of anatomy and surgical procedures is required.
  • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required.
  • This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively.
  • Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007.
  • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP) Good understanding of statistical tools and validation/verification techniques.
  • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required.
  • Legal authorization to work in the United States is required.
  • The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required.

Nice to have

  • An advanced degree (MS or Ph.D.) is strongly preferred.
  • Experience with IDE and PMA submissions.
  • Six-Sigma green belt or black belt certification Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace.
  • Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Compensation

  • $100k-$160k

Benefits

  • The Senior Medical Device R&D Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements.
  • They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards.
  • They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products.
  • The Medical Device Engineer will work with a multidisciplinary team of researchers.

Company info

  • Cresilon ® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology.
  • Cresilon's mission is to save lives.
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