Cresilon is a biotechnology company that develops, manufactures, and markets hemostatic medical devices. The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for medical device products.
Requirements
- 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
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
