Job Description
Contribute your leadership and technical skills in the areas of manufacturing process technologies, problem-solving, training, and project management in a growing medical device company. In this key role, you will be the driving force behind Lean tool implementation and continuous improvement projects site-wide. Your combination of training, motivational skills, analytical problem-solving ability, and passion for Lean manufacturing will be just the right fit for the manufacturing environment of precision instruments for minimally invasive robotic surgery.
Roles & Responsibilities:
- Manufacturing responsibility for tooling/fixtures, manufacturing equipment, and design improvements production.
- Evaluate and challenge mechanism designs for reliability, functionality, and manufacturability. Provide suggested change proposals.
- Evaluate designs for manufacturability (with respect to tooling and assembly methods). Provide suggested change proposals, or tooling concepts during the early design process phase.
- Design, document, and create an efficient “High-volume’ manufacturing assembly line including:
- Workplace and flow process development
- Specify, document, procure, repair, maintain, qualify, and implement fixtures, hand tools, and equipment.
- Determine and incorporate critical feature inspection and test checkpoints into the process. Document if discrepancies, actions or steps are required.
- Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
- Review/approve and determine the impact of ECOs from manufacturing and field perspectives.
- Take responsibility for developing and maintaining compliance with the quality system.
- Evaluate and help in the selection of suppliers for mechanical parts if required. Help resolve supplier quality issues.
- Hire, train, develop and motivate production personnel to follow procedures, and meet high-quality standards, production schedules, and productivity requirements.
- Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness
- Address line support issues as they arise
- Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process
- Provide production personnel with expectations and performance feedback regularly in the production process
- Drive improvements in safety, quality, production, and cost
- Plan, supervise, drive improvement, and report production performance including output, yields, root causes, failures, efficiencies, and trends
- Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System
- Maintain up to date and accessible training records for MPIs and Quality System documents
- Assist in setting and attaining quarterly and annual production goals
- Learn and enforce company safety policies and practices
- Investigate, lead or support sub-assembly or process outsourcing initiatives
- Review and disposition of discrepant material in the manufacturing line. Implement corrective actions to prevent recurrences.
- Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving.
- Design and documentation responsibilities for custom and standard production tooling/fixtures.
- Process and part design/documentation duties for cost reduction programs.
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