Senior Process Engineer/Process Engineer II - Manufacturing

Position Overview

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices using proprietary hydrogel technology. Their plant‐based technology stops traumatic and surgical bleeds in seconds without extended manual pressure, targeting veterinary, human trauma, and human surgical applications. Location: Brooklyn, New York Schedule: Full-Time, On-site.

The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This role plays a key part in ensuring that all manufacturing processes meet quality, compliance, and performance standards while collaborating with Quality, R&D, Regulatory, and Production teams to improve yield, throughput, quality, and efficiency.

Key Responsibilities

• Design, develop, and optimize manufacturing processes for new and existing medical devices.
• Lead process development for new product introductions (NPI), from concept through validation and launch.
• Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost.
• Evaluate and implement automation technologies to improve process consistency and throughput.
• Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues.
• Analyze production data to identify trends, root causes, and opportunities for efficiency.
• Maintain and update validation documentation as part of lifecycle management.
• Ensure processes comply with applicable regulatory requirements and internal quality standards.
• Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions.
• Develop process documentation including SOPs, work instructions, pFMEAs, and equipment qualifications.
• Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration.
• Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives.
• Provide technical leadership and mentorship to junior engineers and technicians (for Senior level).
• Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data.
• Specify, procure, and validate manufacturing equipment and tooling.
• Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards.
• Train manufacturing personnel on new or revised processes and equipment.
• Provide ongoing floor support for manufacturing operations to resolve technical issues in real time.
• Perform other duties as assigned by management.

Required Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
• For Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years in process development, design, and implementation.
• For Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years of hands-on experience in process development, design, and implementation, preferably in medical device, pharmaceutical, or biotech manufacturing.
• Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
• Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA.
• Experience in process design, optimization, and troubleshooting.
• Experience implementing process and quality improvements into manufacturing or CMO environments.
• Strong analytical, problem-solving, and multitasking skills with attention to detail.
• Demonstrated experience training technical personnel.
• Familiarity with data analysis tools and manufacturing software.
• Experience with Lean Manufacturing, Six Sigma, or similar methodologies.
• Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP.
• Ability to manage multiple project assignments and prioritize tasks in a fast-paced environment.
• Experience managing third-party vendors and service providers.
• Ability to work independently as well as collaboratively within cross-functional teams.
• Excellent verbal and written communication skills.
• Ability to become gowning qualified for a cleanroom environment.
• Legal authorization to work in the United States.
• Ability to lift up to 30 pounds and safely move objects as required.
• Strong computer skills with proficiency in Microsoft Excel, Word, and PowerPoint.

Preferred Qualifications

• Master’s degree in Engineering or a related field.
• Experience in the medical device or pharmaceutical industry.
• 3+ years of relevant cGMP manufacturing experience.
• Experience in cleanroom operations, including aseptic processing.
• Experience working with Contract Manufacturing Organizations (CMOs).
• Significant experience with CAD software.
• Experience in supporting regulatory inspections and audit readiness.
• Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience.
• Mechanical/Electrical troubleshooting skills.
• Strong leadership skills with the ability to motivate cross-functional teams.
• Excellent organizational and time management skills.
• Understanding of aseptic processing and microbial control concepts.

Benefits & Perks

• Salary: Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications.
• 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.
• 401(k) & Roth Retirement Savings Plan with company match up to 5%.
• Monthly MetroCard Reimbursement.