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Senior Process Engineer / Process Engineer II - Manufacturing

CresilonBrooklyn, New York, United States
On-site Full-time $90K/yr - $150K/yr

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Experience Level

Mid to Senior

Qualifications

Qualifications:Bachelor's degree in Engineering or a related field. Proven experience in process engineering within a manufacturing environment, preferably in medical devices. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills for effective collaboration across teams. Ability to work in a fast-paced, team-oriented environment. Knowledge of regulatory requirements for medical device manufacturing.

About the job

Cresilon® is a pioneering biotechnology firm located in Brooklyn, New York. We specialize in the development, manufacturing, and marketing of innovative hemostatic medical devices, leveraging our proprietary hydrogel technology. Our groundbreaking, plant-based solutions have transformed the way traumatic and surgical bleeds are managed, achieving swift hemostasis without the necessity for prolonged manual pressure. Our diverse product lines cater to veterinary, human trauma, and surgical applications, embodying our mission to save lives. Discover more about us at www.cresilon.com.

Job Overview:

We are seeking an experienced Senior Process Engineer or Process Engineer II to join our manufacturing team. This position is critical in spearheading the development and optimization of manufacturing processes for our medical device products. You will collaborate with cross-functional teams—Quality, R&D, Regulatory, and Production—to ensure that our manufacturing processes adhere to the highest standards of quality, compliance, and performance. Your role will involve hands-on engagement with the production team, training operators on new processes, troubleshooting equipment issues, and executing qualifications and validations.

This is a full-time, on-site role based in Brooklyn, New York, in a dynamic and collaborative environment that demands creativity and focused execution to enhance production efficiency and establish robust manufacturing processes.

Key Responsibilities:

  • Design, develop, and optimize manufacturing processes for both new and existing medical devices.
  • Lead process development for new product introductions (NPI), guiding projects from concept through validation and launch.
  • Refine manufacturing processes to minimize variability, enhance yield, improve cycle times, and lower costs.
  • Assess and implement automation technologies to boost process consistency and throughput.
  • Collaborate with external vendors and suppliers to specify equipment and troubleshoot product issues.
  • Analyze production data to uncover trends, root causes, and opportunities for increased efficiency.
  • Maintain and update validation documentation as part of lifecycle management.
  • Ensure compliance with regulatory requirements and internal quality standards.
  • Lead investigations into root causes (CAPA, NCRs, SCARs) and implement corrective actions.
  • Create process documentation, including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications.
  • Partner with R&D during the design transfer phase to ensure manufacturability.

About Cresilon

Cresilon is committed to revolutionizing the medical device industry with our innovative hydrogel technology, focused on enhancing patient outcomes and saving lives across various applications.

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