Demo

Manufacturing Manager

The Judge Group
Fife, WA Full Time
POSTED ON 4/7/2025
AVAILABLE BEFORE 5/1/2025

Proven Experience Managing a Medical Device Contract Manufacturing Machine Shop : Ability to oversee day-to-day operations, production schedules, and personnel in a precision ISO 13485-registered machining environment. Led or part of a team scaling manufacturing from ~15 CNC’s to 50.

  • Scaling Manufacturing Growth : Demonstrated ability to scale manufacturing capacity, processes, and teams to support increasing demand and business growth, including strategic planning and resource allocation.
  • Lean Manufacturing and Continuous Improvement : Experience leading and implementing lean methodologies such as Six Sigma, Kaizen, 5S, and Value Stream Mapping to enhance productivity and reduce waste.
  • Experience in Regulated Industries (e.g., medical devices, aerospace, or automotive) : Familiarity with compliance requirements such as ISO 13485, ISO 9001, standards are preferred.

Essential Functions and Duties

Production and Operational Management

  • Lead and manage manufacturing operations, ensuring efficiency, quality, and adherence to timelines.
  • Demonstrate flexibility in adjusting workflows and schedules to meet production demands and resolve bottlenecks.
  • Develop, release, and maintain work instructions, drawings, preventive maintenance schedules, calibration requirements, and spare parts lists.
  • Ensure compliance with 5S standards and promote a culture of workplace organization and safety.
  • Quality Assurance and Inspection

  • Interpret, communicate, and apply GD&T (Geometric Dimensioning and Tolerancing) principles during inspection, production, and job reviews.
  • Operate advanced inspection equipment, including PCDMIS-controlled CMMs and optical comparators, with repeatable precision.
  • Participate actively in Job Reviews and Material Review Board (MRB) meetings to assess non-conforming materials and process improvements.
  • Manage validation efforts and assist with project implementation, ensuring alignment with regulatory and customer quality requirements.
  • Engineering and Technical Support

  • Design and implement fixtures, tools, and gauges to support manufacturing processes.
  • Program CNC machines and other equipment as needed for production.
  • Utilize engineering tools such as FMEA, SPC, MiniTab, and CPK to identify and solve production challenges.
  • Participate in technical reviews, providing detailed data and documentation to support project development and product quality.
  • Lead small projects or portions of larger initiatives, collaborating with cross-functional teams to drive results.
  • Leadership, Coaching, and Team Development

  • Provide coaching, mentorship, and professional development for team members to enhance skills and performance.
  • Manage staff performance, set goals, and conduct performance reviews.
  • Identify and lead productivity improvement projects, driving value for the business.
  • Promote a positive and collaborative work environment, ensuring alignment with company culture and goals.
  • Industry-Specific Knowledge

  • Medical Device Manufacturing : Familiarity with processes and standards in an ISO 13485-registered environment.
  • Knowledge of passivation techniques for medical instruments and devices is a plus.
  • Previous experience preparing for and participating in audits and regulatory inspections.
  • Workload Distribution

  • 30% Engineering / Programming : CNC programming, tooling design, and process optimization.
  • 20% Proving and QA : Inspection, validation, and quality control activities.
  • 10% Documentation / Studies : Creating and maintaining technical documents, including validation reports and manufacturing protocols.
  • 40% Leadership & Staff Management : Mentoring, developing, and managing production teams, ensuring alignment with business goals.
  • Preferred Skills and Competencies

  • Proficient in Mastercam / SolidWorks
  • Proficiency in Minitab or similar software for statistical analysis and process control.
  • Strong understanding of SPC (Statistical Process Control) techniques to ensure product quality.
  • Knowledge of ISO standards and regulatory compliance related to medical manufacturing.
  • Ability to analyze data and generate insights to drive continuous improvement.
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