Sr. Manufacturing Quality Engineer
1 week ago
Autocam Medical is a global contract manufacturer of orthopedic implants, spinal implants, precision instruments and orthopedic cutting tools. We offer a value-added approach to high-precision manufacturing, with specialties in CNC milling, turning and cutter grinding.
This position is under the direction of the General Manager and is responsible for the design, implementation, workings, and methodology to support production and efficiencies. The Manufacturing Engineer analyzes the value stream and identifies opportunities to eliminate non-value-added steps in the process. The Manufacturing Engineer will provide team leadership support for process improvement projects, quality, productivity, and cost reductions.
Responsibilities
- Provide technical troubleshooting/problem solving and training.
- Develop and implement process improvements.
- Perform project management responsibilities for assigned manufacturing changes or new product launches including facilitating and participating in project start-up teams.
- Monitor and improve fixtures, tools, and methods to meet productivity and quality standards.
- Utilize proven lean manufacturing based analytical and troubleshooting/problem solving techniques to identify opportunities for cost reduction, lead-time reduction, inventory reduction and quality improvement through defect reduction.
- Conduct research and development testing and validation to determine effectiveness and compliance to quality standards for the manufacturing processes.
- Confirm conformance to engineering designs and methodologies and verify overall safety. Prepare reports on these activities.
- Optimize floor layout, material flow, along with implementation of lean concepts; document improvements to manufacturing efficiencies, takt time, floor space utilization and overhead.
- Recommend new tools and methodologies including costing and cost estimates for design or product process changes.
- Lead and participate in quality improvement and continuous improvement projects.
- Evaluate existing machinery and processes to recommend improvements that enhance both operator performance and ergonomics/safety of overall production.
- Establish and assist in setting up new jobs and machines.
- Develop or revise technical documentation to specify manufacturing processes, including documentation of equipment qualification, setup, and maintenance procedure.
- Provide accurate and complete engineering documentation.
- Provide visual controls.
- Facilitate and participate project start-up teams.
- Oversee project launch guides from start of purchase order to the finish at PPAP.
- Coordinate and support cross-functional teams, quality, safety, and maintenance.
- Proficiency in Microsoft Office Software, and SolidWorks.
- Project Management and Lean Manufacturing experience.
- Good knowledge of statistical tools, ability to manage multiple tasks.
- Must be flexible and adapt to changing environments and priorities.
- Proven ability to collaborate in a team environment.
- Demonstrated entrepreneurial skills with the ability to work effectively in a fast paced and changing environment with multiple priorities.
- Excellent communication and interpersonal skills.
- Preferred Bachelor's Degree in Manufacturing, Mechanical or Industrial Engineering. Willing to consider alternate Bachelor Degree programs with relevant experience in excess of the requirement below.
- Minimum of 2 years of relevant experience in manufacturing capacity.
- Preferable to understand GMP for Medical Devices FDA 21 CFR Part 820 Quality System Regulation and ISO 13485 Medical Devices - Quality Management Systems or experience working in a regulated industry.
- Proficiency in Microsoft Office Software and SolidWorks.
- Project Management and Lean Manufacturing experience.
- Competitive compensation package
- Health, dental, and vision insurance
- 401(k) retirement plan
- Paid time off and holidays
- Ongoing training and professional development opportunities
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