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.
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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.
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