process engineer Austin, TX
Confluent Medical Technologies
Full Time
Austin, TX
99904 - 74801 USD ANNUAL Today
Job description
We are looking for a
Process Development Engineer, IIto join our talented team in
Austin.
As a uniquely qualified candidate, you will:
As a uniquely qualified candidate, you will:
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 Austin, TX team. As a uniquely qualified candidate, you will:
- Be responsible for process identification, parameter optimization, proof of concept testing, technology improvements, and process implementation.
- Be responsible for tool and fixture design and qualification used for manufacturing medical devices and components.
- Accomplish broad and complex assignments, performing most assignments independently with instructions as to the general results expected. You may also provide technical guidance to lower level personnel.
- Be responsible for screening and optimization of process parameters to achieve robust and stable processes and maximize yields, efficiencies and process capabilities.
- Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
- Apply Six Sigma and Lean Manufacturing principles.
- Design and perform Process Characterization Studies & DOE’s, support protocols and reports.
- Have a firm understanding of process validation strategy (IQ/OQ/PQ), support protocols and reports.
- Work on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors.
- Select techniques to solve complex problems, making sound design recommendations.
- Exercise judgment within defined procedures and practices to determine appropriate action.
- Demonstrate full use and application of standard principles, theories, concepts and techniques.
- Select design direction or modifications of components of systems.
- Plan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project or in a total project of moderate scope.
- Perform work that involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
- Ensure effective training of Manufacturing and Quality Control personnel for transfer of new processes
- Assist the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation
- Use the Enterprise Resource Planning to establish and update parts, BOMs and travelers.
- Comply with company policies and procedures for safety and quality.
- Be responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
- Be responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
Preferred Qualifications:
- Strong in SolidWorks, mechanical acumen and hands-on
- Hands-on experience with a variety of catheter production equipment, such as: hot boxes, die-bonders, braiders, coil winders, laminators, ovens, UV adhesive light welders, laser welders, and others
- Good understanding of materials typical to catheter production: Pebax, Nylon, Polyurethanes, PEEK, PTFE, FEP, CA and UV adhesives, Stainless steel, NiTi, etc.
- Thorough knowledge of ISO 13485 and FDA Quality System requirements
- Knowledge of Design Control requirements as defined by the FDA Quality System regulations
Education and Experience:
BS degree in engineering preferably in Mechanical, Industrial, Biomedical, or Biomechanical Engineering- 2 - 6 years of experience and technical leadership supporting process development. Prefer experience in a ISO 13485 and/or FDA regulated Life Sciences, Medical Device, or Medical Technology industry
- Excellent written and oral communication skills are required
- Highly organized with proven time management and prioritization skills
- Ability to handle the pressure of meeting tight deadlines
- Experience in preparing documentation (work instructions, calibration procedures, analysis spreadsheet, protocols, reports, reference documents and others) in a variety of formats including Word, Excel and PowerPoint
- Familiarity with test method development, calibration, measurement development and Gage R&R analysis desired
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.
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
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.
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.
time-limited visa status for this position.
Confluent Medical Technologies is an equal opportunity employer.
Only qualified candidates will be contacted.
Confluent Medical Technologies
https://confluentmedical.com/
Scottsdale, AZ
Dean Schauer
Unknown / Non-Applicable
1001 to 5000 Employees
Company - Private
Health Care Products Manufacturing
