Process Development Engineer, Senior Staff

Confluent Medical Technologies

24d

About The Position

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’re looking for a Process Development Engineer, Staff to join our Laguna Niguel, CA team. As a uniquely qualified candidate, you will: Work in a team environment to accomplish scientific approaches to balloon and catheter development. Size tooling, materials, and fixtures needed to manufacture components, subassemblies, and assemblies. Create drawings for assemblies, components, and tooling. Design and develop efficient processes and methods for manufacturing. Design and execute DOEs, process analysis/characterization/optimization, protocols, process validation (IQ/OQ/PQ), and reports. Create reports and/or other communications to effectively report engineering findings; utilizing tools such as Minitab. Proficient in polymers such as Nylon 12, Pebax, Polyurethanes, PET, compounds, etc. Works with cross-functional teams to become a pivotal member of Confluent engineering. Lead new product introduction, cost reduction, and revenue generating projects. Generate cost models. Experience with authorship of design control documents for medical devices. Optimize processes to meet manufacturing quality controls, build time, cost, yield targets. Develop test methods. Generate clear and concise work instructions, visual standards, and other related documents. Maintain cleanliness of the work environment. Mentor less experienced engineers. Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. Plans, schedules, conduct, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope.

Requirements

Bachelor of Science in Mechanical or Bio Engineering.
10+ years of experience in medical device development
Authoritative figure in area of expertise.
Strong SolidWorks and AutoCAD skills.
Minitab experience.
Hands-on experience with a variety of catheter or balloon production equipment.
Strong understanding of materials typical to balloons: Pebax, Nylon, Polyurethanes, and PET.
Strong overall knowledge of entire field of work, complex level engineering experience.
Familiar with technical literature and standards related to area of expertise.
Extensive hands-on experience
Leadership skills
Attention to detail, professional attitude, team player

Nice To Haves

Greenbelt or higher training is a plus.

Responsibilities

Work in a team environment to accomplish scientific approaches to balloon and catheter development.
Size tooling, materials, and fixtures needed to manufacture components, subassemblies, and assemblies.
Create drawings for assemblies, components, and tooling.
Design and develop efficient processes and methods for manufacturing.
Design and execute DOEs, process analysis/characterization/optimization, protocols, process validation (IQ/OQ/PQ), and reports.
Create reports and/or other communications to effectively report engineering findings; utilizing tools such as Minitab.
Proficient in polymers such as Nylon 12, Pebax, Polyurethanes, PET, compounds, etc.
Works with cross-functional teams to become a pivotal member of Confluent engineering.
Lead new product introduction, cost reduction, and revenue generating projects.
Generate cost models.
Experience with authorship of design control documents for medical devices.
Optimize processes to meet manufacturing quality controls, build time, cost, yield targets.
Develop test methods.
Generate clear and concise work instructions, visual standards, and other related documents.
Maintain cleanliness of the work environment.
Mentor less experienced engineers.
Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
Plans, schedules, conduct, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope.