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Research and Development Engineer I/II

2 months ago

Brooklyn New York, United States Cresilon, Inc. Full time
About Cresilon, Inc.

Cresilon, Inc. is a leading biotechnology company specializing in the development, manufacturing, and marketing of innovative hemostatic medical devices utilizing proprietary hydrogel technology.

Job Summary

The R&D Engineer I/II is a critical member of our cross-functional team responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements.

Key Responsibilities:
  • Implement formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments.
  • Collaborate with a multidisciplinary team of researchers and engineers to drive product and process innovation.
  • Develop and execute product/process enhancement and new product/process development plans.
  • Lead material/design/process changes and their implementation with well-documented research/analyses.
  • Author protocols and reports, including engineering studies and design verification/validation activities.
  • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control.
  • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis.
  • Participate in voice-of-customer (VOC) labs and other user needs assessments.
  • Interface with external vendors, customers, and suppliers to specify equipment and process requirements.
  • Support process and product transfers to manufacturing or CDMOs.
  • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines.
  • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory.
  • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions.
  • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data.
  • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization.
  • Provide other project or product support as needed to support Cresilon's business objectives.
Requirements:
  • BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline. An advanced degree (MS or PhD) is preferred.
  • Minimum 2 years of previous experience is required for Engineer I and 4+ years experience for Engineer II level. Lab experience in an industry setting within cGMP-regulated environments is strongly preferred.
  • Proficiency as an adept experimentalist with hands-on experience in the process development of polymeric materials and their characterization in an R&D or manufacturing environment.
  • Prior experience developing processes and scaling these up into manufacturing or CDMO is strongly preferred.
  • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment is strongly preferred.
  • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively.
  • Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies.
  • Ability to work independently as well as be a strong team contributor.
  • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills.
  • Experience implementing process and quality improvements in a manufacturing environment preferred.
  • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time.
  • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills.
  • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements.
  • Work experience with the medical device or pharmaceutical industries preferred.
  • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:2007 preferred.
  • Working knowledge of FDA requirements as per 21 CFR 820 preferred.
  • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required.
  • Requires excellent written and verbal communication and presentation skills.
  • Legal authorization to work in the United States is required.
Physical Requirements:
  • Able to be successfully qualified for aseptic gowning, including successful respirator training.
  • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment.
  • Ability to speak, listen, and understand verbal and written communication.
  • Possesses hand-eye coordination and manual dexterity for delicate manipulations.
  • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects.
  • Visual acuity is required for performing close and distant activities.