Introduction to Confluent Medical Technologies
Confluent Medical Technologies is a pioneering force in the medical technology space, dedicated to collaborating with customers to transform their projects from rapid prototypes into high-volume productions. With a strong foundation in innovative material science, engineering, and manufacturing, we have established ourselves as leaders in delivering world-class medical devices. Our capabilities encompass a wide range of products, including Nitinol components, balloon expandable stents, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. Driven by a passion for creating products that meet our clients' visions for their customers, we take pride in our position at the forefront of medical technology.
Job Overview
We are seeking a highly skilled and motivated Process Development Engineer I to join our team in Laguna Niguel, CA. As a Process Development Engineer I, you will play a crucial role in driving innovation and excellence in our manufacturing processes. You will be responsible for process identification, parameter optimization, proof of concept testing, technology improvements, and process implementation. Your expertise will be instrumental in designing and qualifying tools, extrusions, and fixtures used for manufacturing medical devices and components. You will also develop processing parameters for medical devices and components, screen and optimize process parameters to achieve robust and stable processes, and maximize yields, efficiencies, and process capabilities.
Key Responsibilities
- Develop and implement new manufacturing processes and technologies to improve efficiency, quality, and productivity.
- Design and qualify tools, extrusions, and fixtures used for manufacturing medical devices and components.
- Conduct process characterization studies and design of experiments (DOE) to optimize process parameters and improve product performance.
- Develop and maintain detailed documentation, including work instructions, workmanship standards, and engineering memos.
- Analyze data to determine product performance and capability, and make recommendations for improvements.
- Collaborate with cross-functional teams, including project managers, engineers, and technicians, to ensure successful project execution.
- Ensure compliance with company safety, quality policies, and procedures, and actively promote a culture of conformance.
- Stay up-to-date with industry trends, technologies, and regulatory requirements, and apply this knowledge to continuously improve our manufacturing processes.
Essential Qualifications
- Bachelor's degree in Engineering or a related field.
- 0-3 years of experience in a regulated environment, preferably in the medical device industry.
- Strong understanding of mechanical principles, materials science, and manufacturing processes.
- Excellent written and oral communication skills, with the ability to effectively collaborate with cross-functional teams.
- Experience with root cause analysis, problem-solving, and continuous improvement methodologies.
- Familiarity with industry standards and regulations, including ISO 13485 and FDA guidelines.
Preferred Qualifications
- Strong proficiency in SolidWorks, with experience in mechanical design and development.
- Experience with Minitab, or other statistical analysis software.
- Knowledge of balloon blow molding processes, including process parameters, bi-axial orientation, and stress/strain of polymer tubing.
- Experience with blow molding material and tooling design.
- Understanding of materials commonly used in balloon design and production, including Pebax, Nylon, Polyurethanes, and Stainless steel.
- Formal training and experience with mechanical or electrical calibration.
Career Growth and Development
At Confluent Medical Technologies, we are committed to supporting the growth and development of our employees. As a Process Development Engineer I, you will have opportunities to:
- Develop your technical skills and expertise in medical device manufacturing and innovation.
- Collaborate with experienced engineers and technicians to learn from their expertise and share your own knowledge.
- Participate in training and development programs to enhance your skills and stay up-to-date with industry trends and technologies.
- Take on increasingly complex projects and responsibilities as you grow in your role.
- Contribute to the development of new products and technologies, and see the impact of your work on patients' lives.
Work Environment and Company Culture
Our company culture is built on a foundation of innovation, collaboration, and excellence. We value our employees' contributions and recognize the importance of a positive and supportive work environment. As a member of our team, you can expect:
- A dynamic and fast-paced work environment that encourages creativity and innovation.
- A collaborative and supportive team that values open communication and mutual respect.
- Opportunities for professional growth and development, including training and education programs.
- A comprehensive benefits package, including competitive salary, health insurance, and retirement savings plan.
- A company that prioritizes safety, quality, and compliance, and encourages employees to do the same.
Compensation and Benefits
We offer a competitive salary range of $59,625.00 - $99,375.00, depending on experience and qualifications. Our comprehensive benefits package includes:
- Health insurance, including medical, dental, and vision coverage.
- Retirement savings plan, including company match.
- Paid time off, including vacation, sick leave, and holidays.
- Opportunities for professional growth and development, including training and education programs.
- A dynamic and supportive work environment that encourages creativity and innovation.
Conclusion
If you are a motivated and talented engineer looking to make a meaningful contribution to the medical device industry, we encourage you to apply for this exciting opportunity. As a Process Development Engineer I at Confluent Medical Technologies, you will be part of a team that is dedicated to innovation, excellence, and making a positive impact on patients' lives. Please submit your application today and take the first step towards a rewarding and challenging career with our company.
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