Process Development Engineer II

Confluent Medical•Austin, TX

1d•Onsite

About The Position

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes. We are looking for a Process Development Engineer II to join our talented team in beautiful Austin, Texas. As a uniquely qualified candidate, you will: Work in a team environment to accomplish scientific approaches to complex catheter development. Develop and design new process parameters, tooling, and methods for manufacturing complex catheters. Perform Process Characterization Study’s using appropriate statistical techniques including DOE’s, support protocols and reports. Design and develop fixtures and semi-automated equipment for the assembly of complex catheters to meet cost and throughput objectives. Develop and execute validation protocols. 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. Lead new product introduction, cost reduction, and revenue generating projects. Optimize processes to meet manufacturing quality controls, build time, cost, yield targets. Generate clear and concise work instructions, test methods, and visual standards. Maintain cleanliness of the work environment. Mentor less experienced engineers. Perform design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. Plan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project or in a total project of moderate scope. Contribute to the effectiveness of the quality system by actively participating in NCR’s, complaints, CAPA’s, and root cause investigations. Play a technical lead role in projects with moderate complexity as needed to guide, mentor and get results.

Requirements

Bachelor of Science in Materials, Mechanical, Bio Engineering or other relevant degree
3-6+ years of experience in medical device development with a BS
1-4 years of experience in medical device development with a MS
Proficiency in SolidWorks
Familiarity with design control for process development and design development of medical devices
Experience with authorship of design control documents for medical devices
A firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reports
Strong Solidworks skills
Familiarity of a variety of statistical analysis techniques (Ppk, ANOVA, DOE, etc.)
Hands-on experience required, preferably with a variety of catheter or medical device production equipment
Familiarity with technical literature and standards related to area of expertise
Leadership skills
Attention to detail, professional attitude, team player

Nice To Haves

Master’s degree preferred
Minitab experience is a plus
Greenbelt or higher training is a plus
Familiarity with processing catheter materials of: Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes is preferred

Responsibilities

Work in a team environment to accomplish scientific approaches to complex catheter development
Develop and design new process parameters, tooling, and methods for manufacturing complex catheters
Perform Process Characterization Study’s using appropriate statistical techniques including DOE’s, support protocols and reports
Design and develop fixtures and semi-automated equipment for the assembly of complex catheters to meet cost and throughput objectives
Develop and execute validation protocols
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
Lead new product introduction, cost reduction, and revenue generating projects
Optimize processes to meet manufacturing quality controls, build time, cost, yield targets
Generate clear and concise work instructions, test methods, and visual standards
Maintain cleanliness of the work environment
Mentor less experienced engineers
Perform design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
Plan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project or in a total project of moderate scope
Contribute to the effectiveness of the quality system by actively participating in NCR’s, complaints, CAPA’s, and root cause investigations
Play a technical lead role in projects with moderate complexity as needed to guide, mentor and get results