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Manufacturing Operations Manager

2 months ago

Brisbane, Queensland, Australia Avive Solutions, Inc Full time
Job Description

**Job Title:** Manufacturing Operations Manager

**Company:** Avive Solutions, Inc.

**Job Summary:** We are seeking a highly skilled Manufacturing Operations Manager to lead our manufacturing team in the development and implementation of efficient production processes. The successful candidate will have a strong background in manufacturing engineering and a proven track record of improving manufacturing processes and reducing costs.

Key Responsibilities:

  • Plan, design, implement, and validate manufacturing processes for production.
  • Lead efforts to develop manufacturing processes and procedures from early R&D concept/prototype phase to high-volume manufacturing.
  • Lead cross-functional teams to set up and qualify high-volume production facilities in compliance with good manufacturing practices (GMPs) and applicable FDA and ISO quality system regulations.
  • Comply with FDA 21 CFR Part 820 and ISO 13485:2016 quality system regulations used in the medical device industry.
  • Propose and execute growth strategies for the manufacturing team, write job requisitions, conduct interviews, and hire necessary personnel.
  • Develop and manage key performance indicators (KPIs) for the manufacturing process across all production lines.
  • Manage manufacturing equipment/tool design, implementation on production lines, and validation for high-volume production.
  • Author material specifications, tool specifications, supply specifications, standard test methods, bill of material, lot history records, and manufacturing process instructions in compliance with GMPs.
  • Lead process improvement teams to analyze and improve existing processes using lean manufacturing principles.
  • Coordinate with suppliers and other external resources needed in developing and implementing process improvement plans.
  • Use statistical process control concepts and Minitab statistical analysis software to analyze process data.
  • Author test protocols, perform testing, and author reports to support test method validation, design verification, design validation, process validation, intended use validation, flowcharts, PFMEA, DOE, Gage R&R in accordance with FDA and ISO quality system regulations.
  • Generate detailed fabrication drawings using SolidWorks with familiarity of GD&T and tolerance stack-up analysis.
  • Lead packaging design, configuration design, and packaging validation testing to ensure safe packaging.
  • Participate in FDA, ISO, and internal quality audits involving areas of responsibility.
  • Assist with related corrective/preventive action planning and implementation.
  • Interface with the quality group to resolve manufacturing-related CAPAs using different quality tools such as 5 whys, cause and effect diagrams, etc.
  • Contribute to operations functions outside areas of direct responsibility, including but not limited to supplier quality and support fulfilling requirements such as supplier assessments, audits, continuous improvement, etc.
  • Provide mentoring and training to manufacturing engineering technicians and manufacturing engineering assistants in subjects such as equipment maintenance and repair, machine programming and optimization, and other areas of responsibility.
  • Mentor and train other company personnel concerning areas of responsibility.

Requirements:

  • A Master's degree in manufacturing engineering, mechanical engineering, or a closely related field.
  • One year of experience in manufacturing engineering.
  • Experience in manufacturing technologies/processes, including injection molding, machining, welding, additive manufacturing, automation/robotics, plant layout and material handling, lean manufacturing principles, six sigma, problem-solving, quality control, and statistical process control.
  • Familiarity with FDA 21 CFR Part 820 and ISO 13485 quality system regulations.
  • Knowledge of mechanical engineering concepts, including machine design and engineering mechanics.

What We Offer:

  • A competitive salary range of $120,000-$160,000 per year, depending on experience.
  • A dynamic and innovative work environment.
  • Opportunities for professional growth and development.