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Project Engineer CA Open (J#26763)
Education: Bachelors Degree
Experience: 4 - 9 years

Helix Medical is making a world of difference... all around the world.
As a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.

For nearly 30 years, medical device and healthcare companies around the world have looked to Helix Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Helix Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.

We are currently hiring for a Project Engineer - Extrusion who:
*Is the technical lead in design transfer and scale up of extruded silicone products and medical devices
*Enjoys launching new medical device projects and can work with operators to exceed our customer expectations
*Thrives in a fast paced, cutting-edge, lean systems environment, where priorities can often change on a daily basis.

Basic Responsibilities
*Authoring validation strategies, DOE, FMEA risk assessments, technical completion reports, data analysis and completion reports.
*Develop validation protocols and reports (IQ/OQ/PQ - Installation Qualification, Operational Qualification, *Performance Qualification) and provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
*Review proposed new tooling/tooling modifications and repairs to determine the level of validation necessary and coordinate with other functional departments to develop and implement validation test plans.
*Prepare procedures related to process, equipment, test methods and products
*The investigation of EO/DCN (Engineering Change/Document Change Notice) received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes.
*Initiate improvements in current manufacturing methods and process to improve part quality, schedule performance and to reduce manufacturing costs.
*Develop technology strategies and drive innovation of silicone extrusion manufacturing.
*Support manufacturing, engineering and product development to implement new or changing processes.

Required Qualifications
*Bachelor of Science preferably Industrial, Manufacturing or Mechanical Engineering.
*Minimum 7 years experience working as a process, validation or manufacturing engineer in a manufacturing environment.
*Must have at least 3 years of experience in extrusion, silicone extrusion production is preferred.
*Knowledge of silicone materials, silicone extrusion processing equipment, and advanced measurement systems preferred.
*Experience in authoring validation protocols and reports, DOE, FMEA risk assessments, technical report authoring, strong statistical data analysis and recommendation reports.
Must have experience in a structured regulatory environment with advanced quality systems such as ISO13485, ISO 9001, AS9100, TS16949 or equivalent.
Familiarity with statistical problem solving and six sigma techniques to make educated decisions based on data.
Experience with validation protocols and reports, DOE, FMEA risk assessments, technical report authoring, strong statistical data analysis and recommendation reports.
*Attention to detail and able to work independently and on a team with little supervision
*Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers
*Mechanical aptitude

Preferred Qualifications:
*Previous experience Medical device environment and ISO 13485 experience.
*Green Belt certification in Lean or Six Sigma.
*Working knowledge of SolidWorks and AutoCAD software, 2D& 3D.

Its an exciting time to work at Helix Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Helix Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at www.helixmedical.com/careers.

To Apply:
Candidates meeting these qualifications should complete the online application: www.freudenberg.com/en/Career/Vacancies/Pages/details.aspx?jobId=15AD4A1D-4EED-4651-9DF3-9E510B4D162A

Helix Medical is an Equal Employment Opportunity Employer.
 
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