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Senior Manufacturing Process Engineer
2 months ago
Job Type
Full-time
Position Overview
As a key member of our engineering team at Biomerics, you will play a vital role in enhancing our manufacturing capabilities. Your expertise will contribute to the design and implementation of effective manufacturing processes that ensure product excellence and operational efficiency.
- Process Development: Create and refine manufacturing procedures, tools, and fixtures that align with customer requirements while enhancing product quality and ensuring safety for operators.
- Production Support: Provide essential support to production lines, including the execution of process enhancements, troubleshooting machinery, and addressing inquiries from operators.
- Documentation Management: Develop and update manufacturing process documentation, ensuring compliance with established policies and procedures.
- Continuous Improvement: Employ LEAN, Six Sigma, and other industry best practices to drive problem-solving initiatives and foster ongoing improvements.
- Equipment Evaluation: Identify and assess equipment needs on the production floor, exploring both internal and external sourcing options.
- Design Capabilities: Utilize Solid Works to create and modify component and assembly drawings.
- Product Development: Collaborate on the development and launch of new products based on customer or internal specifications.
- Validation Processes: Write and execute validations for processes and equipment (IQ/OQ/PQ).
- Cross-Department Collaboration: Work alongside Research and Development, Marketing, Quality, and Manufacturing teams during the conceptualization, prototyping, and product release phases.
- Quality Audits: Partner with the Internal Audit team to conduct annual quality system audits.
- Vendor Interaction: Engage with external vendors as necessary.
- Maintenance Duties: Perform equipment maintenance in accordance with manufacturer guidelines and established protocols.
- Additional Responsibilities: Undertake other tasks as assigned.
- Bachelor's or Technical Degree in a relevant engineering discipline (Mechanical or Industrial preferred) or a minimum of 5+ years of experience in a medical device manufacturing setting.
- Proven ability to oversee the conception, development, design, and implementation of innovative manufacturing processes and automation.
- Forward-thinking approach to manufacturing technology needs, with a proactive pursuit of development and acquisition.
- Capability to guide product development strategies that incorporate proprietary processes for a competitive edge.
- Experience in LEAN manufacturing methodologies.
- Knowledge of process and equipment validation, including PFMEA, IQ/OQ/PQ.
- Familiarity with CAD software.
- Strong project management skills and a proactive attitude towards project completion.
- Excellent verbal and written communication skills.