Senior Manufacturing Engineer
1 month ago
Summary:
The primary purpose for the Sr. Manufacturing Engineer to contribute technical manufacturing, project management skills, and process excellence thinking to our Operations and New Product Introduction teams. This role combines collaboration with both external and internal customers with active participation and leadership of assigned projects that create and refine our manufacturing methods, designs, and documentation to continually improve our efficiency, reliability, manufacturability, and cost for our product lines.
Duties/Responsibilities:
include the following. Other duties may be assigned:
Applies advanced troubleshooting and root cause analysis methods to solve problems with documented results
Directly supports the operations team
May be called to lead new projects from development through delivery with responsibility for long-term cost, quality, and delivery
Directly supports the qualification and validation activities associated with manufacturing equipment and special processes
Designs and implements robust production processes and methods assuring that process capabilities are adequate to support business needs
Develops work instructions and necessary documentation to train associates and sustain manufacturing proficiencies
Uses statistical and financial analysis to identify trends and opportunities to systemically improve quality, reduce cost, reduce lead time, and reduce scrap
Applies Lean manufacturing and Theory of Constraints tools to optimize processes, workgroups, or cells toward achieving cost, quality, and delivery metrics.
Interfaces with suppliers to explore, test, and implement new manufacturing concepts, tooling, and equipment. Develops and manages project plans, timelines, and budget to support these activities.
Collaboration with internal and external customers to lead the process development and launch of new and revised products
Leads new projects from development through delivery with responsibility for providing reliable quality, cost, and delivery
Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material disposition and ECO implementation
Provide product and process DFx (Manufacturing, Assembly, Inspection) input to enhance manufacturability of new products
Uses statistical and financial analysis to identify trends and opportunities to systematically improve quality, reduce cost, reduce lead time, and reduce scrap
Applies advanced troubleshooting and root cause analysis methods to solve problems with documented results
Generates quotations for new and revised business
This position may have leadership responsibilities as assigned
Competencies/Essential Functions:
Strong background demonstrating proficiency with problem solving and root cause analysis tools
Demonstrate ownership of and ability to manage project assignments with a broad scope and able to prioritize and complete work in a timely manner
Must have the ability to effectively work and communicate within a team and cross functionally to expedite completion of critical project tasks
Solid understanding and ability to lead Lean or TOC improvement initiatives
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
Excellent customer service skills via written and verbal communication required
Strong computer skills (Microsoft Office, Outlook, etc.)
Modeling/drafting experience with Solidworks or similar CAD systems
Working knowledge of drafting standards and geometric dimensioning and tolerancing
Familiarity with MasterCam, Esprit, Partmaker, or similar CAM systems is a plus
Education and/or Experience:
Candidates should have a BS in an Engineering science plus 7 years of manufacturing experience, or an equivalent combination of education and experience
New production introduction/process development experience in a manufacturing environment highly preferred
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