Process Development Engineer II

CONFLUENT MEDICAL TECHNOLOGIES INC.; Austin (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Confluent Medical Technologies in Austin, TX, is seeking a Process Development Engineer II to join our medical device team. You will design and develop process parameters, fixtures, and methods for complex catheters, and lead development projects to improve cost, quality, and throughput.

You will perform DOE-based characterization, validate protocols (IQ/OQ/PQ), generate clear work instructions, and mentor junior engineers while collaborating with cross-functional teams.

Qualifications

• BS in Materials, Mechanical, Bio Engineering or related field.
• MS preferred.
• 3–6+ years in medical device development; BS 1–4 with MS
• Proficiency in SolidWorks
• Familiarity with design control for medical devices
• Experience authoring design control documents
• Strong understanding of validation strategy (IQ/OQ/PQ)
• Hands-on experience with catheter or medical device production equipment
• Familiarity with catheter materials (Polyimide, PTFE, FEP, Pebax, nylons, urethanes)

Responsibilities

• Work in a team to advance catheter development.
• Develop and design new process parameters, tooling, and methods for manufacturing complex catheters.
• Perform Process Characterization Studies using DOE and statistical techniques.
• Design and develop fixtures and semi-automated equipment for assembly of complex catheters.
• Develop and execute validation protocols (IQ/OQ/PQ).
• Lead process improvements to meet quality, cost, and throughput targets.
• Create clear work instructions and test methods.
• Mentor less experienced engineers and collaborate cross-functionally.

Skills

SolidWorks proficiency

Design control knowledge

Statistical analysis (DOE, ANOVA)

Leadership skills

Problem solving

Attention to detail

Education

Bachelor of Science in Materials, Mechanical, Bio Engineering or related

Master's degree 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 Studies 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

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.

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

Our primary capabilities include:

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

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.

Applying materials science to MedTech innovation.

Confluent specializes in expert design and development of large‑scale manufacturing specializing in interventional catheter‑based devices and implants.

Our key capabilities include Nitinol components and tubing, balloon and complex catheters, high‑precision polymer tubing, and implantable textiles.

We operate in 8 state‑of‑the‑art facilities across the United States and Costa Rica and currently employ over 2,000 employees.

Confluent has earned the confidence of leaders in the medical device community through a proven track record of innovation, engineering, and manufacturing.

Visit www.confluentmedical.com to learn more.