Process Development Engineer II

Confluent Medical Technologies; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Confluent Medical Technologies in Austin, TX seeks a Process Development Engineer II to advance catheter manufacturing processes. The role emphasizes hands-on development, design controls, and cross‑functional collaboration to meet quality, cost, and throughput goals.

The position requires strong SolidWorks skills, extensive experience with medical device development, and a track record of leading process improvements and validation efforts. A BS is required with MS preferred.

Qualifications

• B.S. in Materials, Mechanical, or Bio Engineering; MS preferred.
• 3–6+ years in medical device development with a BS or 1–4 years with an MS.
• Proficiency in SolidWorks.
• Experience with design controls and medical device documentation.
• Understanding of IQ/OQ/PQ validation strategies.
• Hands-on experience with catheter or medical device production equipment.
• Familiarity with statistical techniques (DOE, ANOVA, Ppk).

Responsibilities

• Work in a team environment to develop and optimize catheter manufacturing processes.
• Design and develop process parameters, tooling, and methods for catheter production.
• Perform Process Characterization Studies using DOE and related statistics.
• Create fixtures and semi-automated equipment for assembly of complex catheters.
• Develop and execute validation protocols (IQ/OQ/PQ).
• Lead process improvements and contribute to new product introductions.
• Mentor junior engineers and participate in RCAs and CAPAs.

Skills

SolidWorks

DOE

ANOVA

Ppk

Minitab

Design control

Leadership

Attention to detail

Catheter equipment

Education

B.S. in Materials/Mechanical/Bio Engineering

M.S. preferred

Tools

Minitab

Job description

Job Description:

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

Education and Experience:

• Bachelor of Science in Materials, Mechanical, Bio Engineering or other relevant degree. Master’s degree preferred.
• 3-6+ years of experience in medical device development with a BS, 1-4 years 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. Minitab experience is a plus
• Greenbelt or higher training is a plus
• 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
• Familiarity with processing catheter materials of: Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes is preferred
• Leadership skills
• Attention to detail, professional attitude, team player

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 and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. 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 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.