Principal Engineer of Manufacturing Operations

2 weeks ago

Minneapolis, Minnesota, United States Biomerics Full time

Job Type:

Full-time

Position Overview:

As a Principal Manufacturing Engineer at Biomerics, you will play a pivotal role in enhancing our manufacturing capabilities and ensuring the highest standards of product quality and safety.

  • Manufacturing Process Development: Design and refine manufacturing protocols, tools, and fixtures to achieve optimal production capacity while maintaining product integrity and safety for operators.
  • Production Support: Provide essential support to the production line by implementing process enhancements, troubleshooting machinery, and addressing inquiries from operators.
  • Documentation Management: Create and update manufacturing process documentation, ensuring compliance with established guidelines and procedures.
  • Continuous Improvement: Apply LEAN, Six Sigma, and other best practice methodologies to foster day-to-day problem-solving and drive ongoing improvements.
  • Equipment Assessment: Identify equipment requirements on the production floor and evaluate both internal and external options for procurement.
  • Technical Drawing Generation: Produce and modify component and assembly drawings utilizing SolidWorks software.
  • Product Development: Collaborate in the development and launch of new products based on customer or internal specifications.
  • Validation Processes: Author and execute process and equipment validations (IQ/OQ/PQ) to ensure compliance and reliability.
  • Cross-Department Collaboration: Work alongside Research and Development, Marketing, Quality, and Manufacturing teams during the concept, prototyping, and product release phases.
  • Quality Audits: Partner with the Internal Audit team to conduct scheduled quality system audits.
  • Vendor Relations: Engage with external vendors as necessary to support manufacturing needs.
  • Equipment Maintenance: Conduct maintenance on equipment by adhering to 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 design, development, and implementation of innovative manufacturing processes, procedures, and automation.
  • Capability to anticipate future manufacturing technology requirements and actively seek development opportunities.
  • Expertise in steering product development strategies to incorporate proprietary processes for competitive advantage.
  • Experience in LEAN manufacturing principles.
  • Knowledge of process and equipment validation, including PFMEA, IQ/OQ/PQ.
  • Proficiency in CAD software.
  • Strong project management skills and a proactive approach to project completion.
  • Excellent verbal and written communication abilities.

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