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.

Education & Certifications: Minimum of BS in Mechanical, Biomedical Engineering or directly related scientific discipline. Work Experience: Minimum of 10 years' experience in a medical device manufacturing environment is required. FDA regulated work experience required. Demonstrated experience leading process validations (IQ/OQ/PQ) and manufacturing process development required.

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