Process Development Engineer, Senior Staff

Confluent Medical Technologies, Inc.; Austin (TX); Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

Confluent Medical Technologies, Inc. is seeking a Senior Staff Process Development Engineer in Austin, TX to lead the development of manufacturing processes for complex catheters.

You will drive process characterization, validation, and optimization in collaboration with cross-functional teams. Responsibilities include designing fixtures and semi-automated equipment, mentoring engineers, and ensuring quality and productivity targets are met.

Qualifikationen

• Bachelor of Science in Mechanical, Chemical, or Bio-Engineering (or equivalent experience).
• Hands-on experience with medical device manufacturing and catheter processes.
• Strong knowledge of DOE, ANOVA, and statistical methods.

Aufgaben

• Develop manufacturing processes for complex catheters and assemblies.
• Perform process validation (IQ/OQ/PQ) and design verification.
• Lead cross-functional teams to optimize quality, cost, and throughput.

Kenntnisse

DOE methods

Statistical analysis

Leadership

Ausbildung

B.S. Mechanical/Chemical/Bio-Engineering

Tools

SolidWorks

Minitab

Jobbeschreibung

Job Description: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.We are looking for a Process Development Engineer, Senior Staff to join our Austin, TX team. As a uniquely qualified candidate, you will: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 engineeringSupport new product introduction, cost reduction, and revenue generating projectsDevelop 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 objectivesTechnical support manufacturing including production related matters involving day to day troubleshootingTrain production personnel as requiredMaintain 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 investigationsEducation and Experience: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 developmentHands-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 preferredExperience applying a variety of statistical analysis techniques (Ppk, ANOVA, DOE, etc.)Experience designing fixtures and simple semi-automated equipment using SolidWorks is preferredAuthoritative 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 experienceLeadership skillsAttention to detail, professional attitude, team playerWe regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.Confluent Medical Technologies is an equal opportunity employer.Only qualified candidates will be contacted.