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About the Role

Confluent Medical Technologies is seeking a Process Development Engineer, Senior Staff to join their Austin, TX team. This role involves developing manufacturing processes for complex catheters, performing process analysis and validation, and supporting new product introductions. The engineer will work collaboratively with cross-functional teams to achieve scientific approaches to complex catheter development and ensure world-class medical device production.

Responsibilities

Work in a team environment to accomplish scientific approaches to complex Catheter development.
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.
Works 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 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.
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 NCR’s, complaints, CAPA’s, and root cause investigations.

Requirements

Bachelor of Science in Mechanical/Chemical/Bio-Engineering. Equivalent work experience maybe considered in extenuating circumstances.
9-12 years of experience in medical device manufacturing and development.
Hands-on experience with a variety production equipment used in complex catheters manufacturing process is preferred (Braiding, Lamination, extrusion, laser welding, hot bonding).
Strong materials process understanding of: Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes is preferred.
Experience applying a variety of statistical analysis techniques (Ppk, ANOVA, DOE, etc.).
Experience designing fixtures and simple semi-automated equipment using SolidWorks is preferred.
Authoritative figure in area of expertise.
Greenbelt or higher training is preferred.
Strong overall knowledge of entire field of work, complex level engineering experience.
Familiar with technical literature and standards related to area of expertise.
Extensive hands-on experience.
Leadership skills.
Attention to detail, professional attitude, team player.
We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.

Skills

Complex Catheter development
Process development
Process analysis
Process improvement
Process validation (IQ/OQ/PQ)
Statistical analysis techniques (DOE, Ppk, ANOVA)
Design of experiments (DOE)
SolidWorks
Fixture design
Semi-automated equipment design
Braiding
Lamination
Extrusion
Laser welding
Hot bonding
Polyimide
PTFE
FEP
Pebax
Nylons
Urethanes

Location

Austin, TX

Work Type

Full-time

Experience Level

Senior Staff
9-12 years

Education Level

Bachelor of Science in Mechanical/Chemical/Bio-Engineering

About the Company

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production.
Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing.
Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.
We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

Equal Opportunity

Confluent Medical Technologies is an equal opportunity employer.