Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for medical device products. This role requires a strong operational, quality, and technical background, with experience in process validation, root cause analysis, and CAPA.
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
- Competitive annual base salary range of $90,000 - $150,000
- 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
