Process and Manufacturing Engineer

hace 1 día

Alajuela, Alajuela, Costa Rica Freudenberg Group A tiempo completo $60.000 - $120.000 al año

Working at Freudenberg: "We will wow your world" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

Cafeteria/ Canteen

Diversity & Inclusion

On-site Medical Service

Sustainability & Social Commitment

Health Insurance

Alajuela

On-Site

Freudenberg Medical srl.

You support our team as

PROCESS AND MANUFACTURING ENGINEER

Responsibilities

  • Responsible of manufacturing schedule and its compliance.
  • Responsible to generate, document and close of manufacturing work orders, controls of the materials to perform each work order, complete the manufacturing documentation and manage the ERP in manufacturing module.
  • Develop and support the validation protocols and reports (IQ-Installation Qualification, Operational Qualification OQ-PQ-Performance Qualification). Provide objective evidence that the equipment, processes, test methods and product meet all requirements and are in compliance with the Medical Devices regulations.
  • Responsible for quality incident resolution into existing processes and production.
  • Responsible for the development of engineering studies and capacity analysis.
  • Responsible for maintaining and controlling the production capacity model.

Qualifications

  • Minimum 3 years experience working as a process, Manufacturing or project engineer.
  • Bachelor of Science degree in engineering (Mechanical, Electro-Mechanical, Chemical, Materials and Industrial engineering).
  • Technical experience in assembly lines.
  • Previous experience working in a Manufacturing environment.
  • Bi-lingual, at least B2 (Ingles-Spanish).
  • Familiarity with statistical problem solving and six sigma techniques.
  • Experience with validation protocols and reports, DOE, FMEA risk assessments, technical report authoring, strong statistical data analysis and recommendation reports.
  • Attentive to detail.
  • Good written and spoken communication skills.
  • Previous experience in a manufacturing environment of medical or Healthcare products and familiarity with ISO-13485 and FDA CFR 21 regulations.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Additional Information

Roy Vargas

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