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Senior Manufacturing Process Engineer

2 months ago


Minneapolis, Minnesota, United States Biomerics Full time

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.
Qualifications
  • 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.