Process Development Engineer, Senior Staff

Confluent Medical Technologies

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 environment reflects a culture of growth, leadership, and innovation in which our employees can directly impact the world by doing work that truly matters. We’re looking for a Process Development Engineer, Sr. Staff to join our team in beautiful Laguna Niguel, CA. As a uniquely qualified candidate, you will:  Work in a team environment to accomplish scientific approaches to extrusion and balloon development  Perform process analysis, improvements and process validation (IQ/OQ/PQ)  Develop and execute validation protocols  Create reports and/or other communications to effectively report engineering findings  Work with cross-functional teams to become a pivotal member of Confluent engineering  Develop and design new process parameters, tooling, and methods for extrusion manufacturing  Lead new product introduction, cost reduction, and revenue generating projects  Potentially support engineering projects or cross-train in the area of polymer extrusion  Optimize processes to meet manufacturing quality controls, build time, cost, yield targets  Generate clear and concise work instructions, test methods, and visual standards  Design and perform Process Characterization Study’s & DOE’s, support protocols and reports  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

Requirements

Bachelor or Masters of Science in Mechanical or Bio Engineering.
9-12 years of experience in medical device development
Authoritative figure in area of expertise including extrusion of medical devices
Experience with polymer testing methodologies such including FTIR, DSC, MA
Proficient in medical grade polymers such as Nylon 12, PBAX, Polyurethanes, PET with knowledge and experience in polymer science
Experience with authorship of design control documents for medical devices
Proficient in AutoCAD to create drawings for balloons, extrusion, and tooling required in balloon development
Ability to work independently and support multi-sites
Strong Solidworks and AutoCAD skills
Strong Minitab experience
Hands-on experience with a variety of catheters, balloons, and extrusion production equipment
Strong understanding of biomaterials 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
Ability to work independently
Leadership skills
Problem solving 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 extrusion and balloon development
Perform process analysis, improvements and process validation (IQ/OQ/PQ)
Develop and execute validation protocols
Create reports and/or other communications to effectively report engineering findings
Work with cross-functional teams to become a pivotal member of Confluent engineering
Develop and design new process parameters, tooling, and methods for extrusion manufacturing
Lead new product introduction, cost reduction, and revenue generating projects
Potentially support engineering projects or cross-train in the area of polymer extrusion
Optimize processes to meet manufacturing quality controls, build time, cost, yield targets
Generate clear and concise work instructions, test methods, and visual standards
Design and perform Process Characterization Study’s & DOE’s, support protocols and reports
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