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.
Qualifications :
- Strong Lean manufacturing implementation and training experience are an absolute requirement! Six Sigma background and knowledge is also highly desirable.
- Must be a hands-on team player with a broad background able to interact cross-functionally to develop improvement strategies and implement solutions. We need someone with an unfailing commitment to continuous improvement.
- 6-8 years of Manufacturing engineering experience is required.
- BSME required.
- MSME preferred.
- Customs and material department knowledge preferred
- Must be able to work in 12 hr. Shifts (4x3)
- Strong communications skills across team organizations and cultures.
- Interface with shipping and receiving activities preferred.
- Mid/high volume complex mechanism manufacturing engineering experience preferred.
- New product introduction/development desirable. Robotics knowledge is a plus.
- Experienced in ISO 13485 or medical device manufacturing environment.
- CAD experience preferred (ProE AutoCAD).
- Data analysis capabilities (use of Minitab Is preferred)
- Must be able to speak read and write in English 80%.
- Must be able to travel to the USA
Additional Information :
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminacin y acoso independientemente de su raza sexo condicin de embarazo orientacin sexual identidad de gnero origen nacional color edad religin condicin de veterano protegido o de discapacidad informacin gentica o cualquier otra condicin protegida por las leyes federales estatales o locales aplicables.
Remote Work :
No
Employment Type :
Full-time