Process Development Engineer, Sr. Staff

Job duties

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Work in a team environment to accomplish scientific approaches to complex Catheter development

(medical devices).

Develop manufacturing processes for products in the area of complex catheters. Perform process analysis, improvements and process validation (IQ/OQ/PQ). Create reports and/or other communications to effectively report engineering findings. Work with cross-functional teams to become a pivotal member of Confluent engineering. Support new product introduction, cost reduction, and revenue generating projects. Develop and design new process parameters, tooling, and methods for manufacturing. Optimize processes to meet manufacturing quality controls, build time, cost, yield targets. Generate clear and concise work instructions, test methods, and visual standards. Perform Process Characterization Studys and DOEs, support protocols and reports. Technical support manufacturing including production related matters involving day to day troubleshooting. Train production personnel as required. Maintain cleanliness of the work environment. Mentor less experienced engineers. Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. Practice company safety and quality, policies and procedures that actively require conformance. Contribute to the effectiveness of the quality system by actively participating in NCRs, complaints, CAPAs, and root cause investigations. Responsible for equipment optimization (maximizing equipment utilization). Maintain knowledge in line balancing. Reduce physical footprint by improving the layout through fixture implementation and other process optimizations.

Up to 15% domestic/international travel.

Education and Experience required

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Bachelors degree in Mechanical Engineering, Mechatronic Engineering, Electromechanical Engineering, Chemical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering or a related engineering discipline and

9 years of experience in medical device manufacturing and development.

Background

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9 years of experience

with a variety of production equipment used in complex catheters manufacturing process, including Braiding, Lamination, extrusion, laser welding, hot bonding and adhesive bonding technologies.

5 years of experience with the materials process including Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes.

5 years of experience supporting or transferring medical device products in a high- volume production environment.

5 years of experience leading a team of Process Engineers and Process Engineering Technicians with responsibility for their development and accountability for project and process deliverables. 5 years of experience creating and reviewing complex work instructions and acting as a liaison with production operations for operator training. 5 years of experience with enterprise resource planning (ERP) software creating part masters, bills of material and travelers. 9 years of experience creating process flow maps, capacity plans, characterization (DOE, optimization processes), and time study analysis. 5 years of experience working with teams in multiple sites and the ability to act as a technical liaison for process and product issues. 5 years of experience supporting validation and qualification processes (IQ, OQ, PQ and PPQ) including execution and reporting. 5 years of experience in fixture design to improve process manufacturability and ergonomics.

Location

- Austin, TX

Ho

w to apply

- By email to

...

with #CMTPDE in the subject line.