Cresilon
Headquartered in Brooklyn, New York, Cresilon, Inc. is a privately-held medical device company focused on hemostatic technologies that improve wound care and advance the standard of medical treatments$1. .$1
51 - 200
Manager Process Engineering R&D (Chemical Process & Medical Device)
2 days ago
🏢 In-office - Brooklyn
Cresilon
Headquartered in Brooklyn, New York, Cresilon, Inc. is a privately-held medical device company focused on hemostatic technologies that improve wound care and advance the standard of medical treatments$1. .$1
51 - 200
Description
• The Process Engineering Manager is responsible for overseeing all aspects of process engineering in the development and scale-up of Cresilon's hemostatic medical devices. • This includes but is not limited to, directing all process development, scale-up, tech transfers, validations, improvements, and implementations. • Critical to the individual's success includes the successful harmonization into existing facility engineering systems. • They will also have some involvement in facility maintenance operations and facilities design/renovation especially as it pertains to process implementation. • The ideal candidate will have experience in chemical or polymer materials processing and experience in biotechnological applications. • This role reports directly to the Vice President of Technology.
Requirements
• Bachelor’s degree in chemical engineering, biomedical engineering, materials engineering, or equivalent required. • MS degree in a closely related technical field or MBA preferred. • 5+ years of experience in process innovation, development and implementation to manufacturing environments is required. Preferred expertise is ideally in chemical/polymer processes and in controlled manufacturing environments (cGMP, aseptic, etc.). • A minimum of 5 years of direct management experience is required, with the ability to manage engineers, scientists, and technicians and influence, motivate, and drive technical rigor. • Hands-on, roll-up-your-sleeves approach with a high sense of urgency and drive for results, balancing creativity with implementation. • Expertise in technical process design, development, implementation, and process technology transfer with a thorough understanding of regulatory requirements. • Experience in chemical and polymer processes, including formulation and purification is strongly preferred. • Experience with semisolid aseptic formulation and syringe filling lines is strongly preferred. • Demonstrated experience managing third-party vendors and service providers. • Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGMP, and related standards (e.g., ISO 13485) is preferred. • Demonstrated ability to execute priorities in a fast-paced environment, working under pressure with tight timelines, with the ability to maintain a sense of priorities focus, and urgency. • Requires strong leadership, organizational and project management skills, a keen attention to detail and multi-tasking prowess. • Working knowledge of industry-standard schematic capture and mechanical design CAD tools preferred • Ability to identify and analyze complex technical problems and implement innovative solutions is required. • Ability to extract key facts from complex information and present concise summaries to management. • Knowledge of Lean Manufacturing principles and Six Sigma Black Belt certification is strongly preferred. • Demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resources strategically and according to the portfolio priorities. • Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) are required. • Experience working under pressure with tight timelines with the ability to maintain a sense of priorities focus and urgency. • Extensive experience with using project management and/or collaboration tools (e.g., Microsoft Project) is required. Strong working knowledge of Microsoft Office is required. • Legal authorization to work in the United States is required.
Benefits
• Paid Vacation, Sick, & Holidays • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage • Company Paid Life and Short-Term Disability Coverage • Work/Life Employee Assistance Program • Monthly MetroCard Reimbursement • 401(k) & Roth Retirement Savings Plan with company match up to 5%
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