Engineer Sr - Manufacturing - ACT at Arthrex California Technology, Inc.
Posted in Engineering 30+ days ago.
This job brought to you by eQuest
Location: Santa Barbara, California
|Title:||Engineer Sr - Manufacturing - ACT|
|Division:||Arthrex California Inc (US03)|
|Location:||ACT Santa Barbara, CA (US02)|
Design, develop, implement and improve manufacturing and supplier processes to produce cost effective quality medical device products. Leader in process development for yield improvement and cost reduction activities. Manage the process for the efficient transfer of product designs to manufacturing. Recognized as a technical manufacturing resource.
Essential Duties and Responsibilities:
- Develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence by leading process improvement initiatives.
- Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices by leading multifunctional project teams to facilitate new products into manufacturing.
- Develop action plans to achieve short and long-range efficiency goals, develop new production methods, design assembly fixtures using SolidWorks and perform IQ OQ PQ to qualify new equipment.
- Works with cross functional teams to develop low cost, high yield manufacturing operations. Improve process repeatability / reproducibility and yield enhancement.
- Responsible for manufacturing bills of material, process documentation tracking / monitoring and reporting upon process yields and failure root cause investigations.
- Develop manufacturing Work Instructions. Provide daily process support on manufacturing issues.
- Designs tooling and fixturing to support process improvements for medical device manufacturing
- Evaluate and approve engineering changes, develop protocols and write process validation documents.
- Establish process flow diagrams, process layouts, develop TAKT and touch labor standards.
- Facilitate kaizen events targeting key improvements to drive productivity improvement projects
- Drives automation to replace manual processes based upon Return On Investment calculations
- Applies statistical methods to manufacturing process data to drive process improvements projects.
- Possesses the ability to supervise, assign, and coordinate the work of others as appropriate.
Education and Experience:
- Bachelor’s degree in Engineering, Science or Mathematics required
- 7 years of relevant Manufacturing Engineering experience required
- Proven experience in work flow optimization, yield tracking, new product introduction
- Proficient at driving Failure Analysis and Root Cause Determination with effective solutions
- Medical device manufacturing environment preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Recognized process improvement training (Lean, Six Sigma) preferred.
- Demonstrated Strong Project Management skills to manage projects to timely completion
- Ability to analyze data collected using statistical methods and related software programs
- Strong communication skills, ability to communicate effectively with technical and non-technical staff.
- Experienced user of MS Office Suite, SolidWorks and production simulation software.
- Experienced in compiling technical documentation in a regulated industry.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word, Playbook, QAD / SAP or similar ERP software. Familiarity with SolidWorks or other 3D modeling software. Experience with Medical Device Equipment development manufacturing and testing.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.