Process Development Engineer II

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

Job summary

Confluent Medical Technologies, Inc. is seeking a Process Development Engineer II in Austin, TX to advance catheter manufacturing processes.

You will design process parameters, tooling, and semi-automated equipment, conduct DOE-based characterization, and lead validation activities (IQ/OQ/PQ) while collaborating across engineering teams to deliver high-quality medical devices. The role requires a BS or MS in a relevant field with 3–6+ years in medical device development, proficiency in

Qualifications

• BS in Materials, Mechanical, Bio Engineering or related field; MS preferred.
• 3–6+ years medical device development experience.
• Proficiency in SolidWorks; familiarity with design controls.
• Experience with IQ/OQ/PQ validation and protocol/report writing.
• Experience in catheter or medical device production equipment.
• Statistical analysis: DOE, ANOVA, Ppk.
• Leadership and cross-functional teamwork.

Responsibilities

• Work in a team to develop catheter manufacturing processes.
• Design new process parameters, tooling and methods for catheter manufacturing.
• Conduct Process Characterization Studies using DOE.
• Develop fixtures and semi-automated equipment for catheter assembly.
• Execute validation protocols (IQ/OQ/PQ).
• Perform process analysis, improvements and validation.
• Create reports and communications reporting engineering findings.
• Lead NPI, cost reduction, and revenue projects.
• Optimize processes to meet quality, build time, cost and yield targets.
• Generate work instructions, test methods, and visual standards.
• Mentor less experienced engineers.
• Participate in NCRs, CAPA, and root cause investigations.
• Plan and coordinate phases of engineering work on projects.
• Contribute to quality system improvements.

Skills

SolidWorks

Minitab

DOE

ANOVA

Design controls

Leadership

Attention to detail

Team player

Statistical analysis

Education

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

Master's degree preferred

Tools

SolidWorks

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 developmentDevelop and design new process parameters, tooling, and methods for manufacturing complex cathetersPerform 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 objectivesDevelop and execute validation protocolsPerform process analysis, improvements and process validation (IQ/OQ/PQ)Create reports and/or other communications to effectively report engineering findingsWork with cross-functional teams to become a pivotal member of Confluent engineeringLead new product introduction, cost reduction, and revenue generating projectsOptimize processes to meet manufacturing quality controls, build time, cost, yield targetsGenerate clear and concise work instructions, test methods, and visual standardsMaintain cleanliness of the work environmentMentor less experienced engineersPerform design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processesPlan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project or in a total project of moderate scopeContribute to the effectiveness of the quality system by actively participating in NCR’s, complaints, CAPA’s, and root cause investigationsPlay a technical lead role in projects with moderate complexity as needed to guide, mentor and get resultsEducation 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 MSProficiency in SolidWorksFamiliarity with design control for process development and design development of medical devicesExperience with authorship of design control documents for medical devicesA firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reportsStrong Solidworks skills. Minitab experience is a plusGreenbelt or higher training is a plusFamiliarity 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 equipmentFamiliarity with technical literature and standards related to area of expertiseFamiliarity with processing catheter materials of: Polyimide, PTFE, FEP, Pebax, Nylons, and Urethanes is preferredLeadership skillsAttention to detail, professional attitude, team playerConfluent 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.