Cresilon · 4 months ago
Senior Process Engineer/Process Engineer II - Manufacturing
Brooklyn, NY
Full-time
Onsite
Mid, Senior Level
$90K/yr - $150K/yr
10+ years expCresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing proprietary hydrogel technology. The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for medical device products, ensuring that all processes meet quality, compliance, and performance standards while collaborating with cross-functional teams.
BiotechnologyHealth CareMedicalMedical Device
No H1B
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 standard operating procedures (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, helping to resolve technical issues in real time
Other duties may be assigned as deemed necessary by management
Qualification
Required
Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field
Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required
Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, 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
Proven experience in process design, optimization, and troubleshooting
Experience implementing process and quality improvements into manufacturing or CMO
Strong analytical and problem-solving skills
Ability to multitask and prioritize work, while remaining detail-oriented
Demonstrated experience training technical personnel
Familiarity with data analysis tools and manufacturing software
Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies
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 handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner
Demonstrated experience managing third-party vendors and service providers
Demonstrated ability to work independently as well as be a strong team contributor
Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks
Excellent verbal and written communication skills required
Ability to become gowning qualified to work in a cleanroom environment
Ability to speak, listen, and understand verbal and written communication in English
Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects
Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Legal authorization to work in the United States
Preferred
Master's degree in Engineering or related field
Experience in medical device or pharmaceutical
3+ years of relevant cGMP manufacturing experience
Experience in cleanroom operations, including aseptic processing
Experience with 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 knowledge with the ability to troubleshoot equipment
Strong leadership skills with the ability to influence and motivate a cross-functional team
Organizational and time management skills with the ability to prioritize a variety of tasks/projects
Demonstrated understanding of aseptic processing and microbial control concepts
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
401(k) & Roth Retirement Savings Plan with company match up to 5%
Monthly MetroCard Reimbursement
Company
Cresilon
Cresilon is a medical device company that produces and markets solutions for trauma care.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$100.66MKey Investors
Paulson Investment Company
2025-09-09Series Unknown· $23.86M
2022-10-27Series A· $25M
2021-04-08Series A· $14M
Leadership Team
Isaac Miller
EVP, Co-Founder
Scott Levine
Chief Financial Officer
Recent News
Crain's New York Business
2025-09-10
2025-09-06
Company data provided by crunchbase