Sr. Manufacturing/Process Engineer

Duties and Responsibilities:

• Lead the development, validation, and continuous improvement of manufacturing and process technologies for medical device products in accordance with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485. 
• Serve as a senior technical resource for manufacturing and process engineering activities across multiple product lines. 
• Lead complex, cross-functional projects from concept through commercialization, including new product introductions, line extensions, and transfers from R&D to manufacturing. 
• Develop, qualify, and validate new manufacturing processes and equipment, including authorship and execution of IQ/OQ/PQ protocols, test method validations (TMV), and process validation reports. 
• Create and maintain the process validation master plan. 
• Apply statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (MSA/Gage R&R), and process capability analysis to develop, characterize, troubleshoot, and control manufacturing processes. 
• Lead risk management activities for manufacturing processes, including authorship and review of PFMEAs. 
• Drive Design for Manufacturability (DFM) input during product development and design transfer activities. 
• Identify, evaluate, and implement opportunities to reduce cycle time, scrap, and manufacturing cost; develop and execute plans to capitalize on these opportunities. 
• Apply Lean manufacturing principles and continuous improvement methodologies to optimize production workflows, layouts, and equipment utilization. 
• Lead the evaluation, specification, design, and qualification of tools, fixtures, custom equipment, and production systems to meet capability and capacity requirements. 
• Monitor process output, yield, and scrap; analyze trends and drive corrective actions to improve performance. 
• Perform and oversee cleanroom (Class 8) validations as required. 
• Manage activities with outside vendors and contract manufacturers providing components, assemblies, processes, testing, and other services. 
• Lead investigations of nonconformances and support CAPA activities, including root cause analysis and effectiveness checks. 
• Author, review, and approve standard operating procedures, work instructions, engineering change orders, and related quality system documentation. 
• Train production operators and technicians on new processes and ensure adherence to process standards. 
• Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485. 
• May supervise and provide technical direction to engineers, technicians, and operators; mentor junior engineers and technicians. 
• Present project status, technical findings, and recommendations to cross-functional teams and management. 
• Maintain effective communications with supervisor, peers, and stakeholders. 
• Provide strategic direction for specific projects and contribute to departmental planning. 
• Support day-to-day manufacturing activities as needed.

Qualifications

Education & Certifications:

• Minimum of BS in Mechanical, Biomedical Engineering or directly related scientific discipline.

Work Experience:

Knowledge, Skills & Abilities:

• Able to read, write and understand English.
• Strong working knowledge of FDA 21 CFR Part 820 and ISO 13485. 
• Proficiency in statistical methods including DOE, SPC, MSA, and process capability analysis. 
•  Working knowledge of design controls, risk management, and CAPA processes. 
• Familiarity with Lean manufacturing and continuous improvement methodologies. 
• Strong project management and technical leadership skills.

Physical Requirements: 

• Able to work in both office and industrial/cleanroom environments