Engineering Specialist

Medial Group; Puerto Rico; Sur place; USD 65 000 - 95 000; Plein temps

Résumé du poste

Medial Group in Puerto Rico is seeking a Manufacturing Process Engineer to design and optimize production layouts, lead process development, and drive validation activities for new products. The role requires expertise in injection molding and qualification lifecycles, with a focus on compliant manufacturing practices and on-site collaboration.

The successful candidate will develop SOPs, support scale-up, ensure quality system compliance, and provide floor-level support across multiple

Qualifications

• Minimum 2 years of experience in a regulated manufacturing environment.
• Strong knowledge of Injection Molding processes and tooling.
• Experience with the process validation lifecycle: IQ, OQ, PQ, TMV, PFMEA.
• Proficiency in technical drawing interpretation and GD&T.
• Strong problem-solving and analytical skills with attention to detail.
• Ability to work independently and cross-functionally in fast-paced environments.
• Excellent written and verbal communication skills in English (Spanish is a plus).

Responsabilités

• Design, plan, and optimize layouts for production processes (machining, metal forming, plastics processing, assembly, materials handling).
• Lead process development, documentation, and execution to support new product introduction.
• Prepare and execute equipment validation activities (IQ, OQ, PQ) and support process characterization, TMV, and PFMEA.
• Develop and update Standard Operating Procedures (SOPs) for new and existing processes.
• Design and implement line layout and infrastructure to support production scale-up.
• Generate and maintain special build documentation and provide on-the-floor line support to manufacturing teams.
• Inspect machinery and equipment to verify efficiency, troubleshoot deficiencies, and drive corrective actions.
• Ensure compliance with company programs, procedures, and applicable quality system regulations and standards.
• Leverage technical expertise and knowledge of standard engineering approaches and specifications to best utilize equipment and manufacturing techniques.

Connaissances

Regulated manufacturing experience

Injection Molding knowledge

Process validation lifecycle (IQ/OQ/PQ

GD&T interpretation

Problem-solving & analytical skills

Independent & cross-functional work

English communication skills

Description du poste

• Design, plan, and optimize layouts for production processes (machining, metal forming, plastics processing, assembly, materials handling).
  
• Lead process development, documentation, and execution to support new product introduction.
  
• Prepare and execute equipment validation activities (IQ, OQ, PQ) and support process characterization, TMV, and PFMEA.
  
• Develop and update Standard Operating Procedures (SOPs) for new and existing processes.
  
• Design and implement line layout and infrastructure to support production scale-up.
  
• Generate and maintain special build documentation and provide on-the-floor line support to manufacturing teams.
  
• Inspect machinery and equipment to verify efficiency, troubleshoot deficiencies, and drive corrective actions.
  
• Ensure compliance with company programs, procedures, and applicable quality system regulations and standards.
  
• Leverage technical expertise and knowledge of standard engineering approaches and specifications to best utilize equipment and manufacturing techniques.
  

*Other duties maybe assigned.*

Requirements

• Minimum 2 years of experience in a regulated manufacturing environment.
  
• Strong knowledge of Injection Molding processes and tooling.
  
• Proven experience with the process validation lifecycle: Installation Qualification (IQ), Test Method Validation (TMV), Process Characterization, Operational Qualification (OQ), Performance Qualification (PQ), and PFMEA.
  
• Proficiency in technical drawing interpretation and GD&T.
  
• Strong problem-solving and analytical skills with attention to detail.
  
• Ability to work independently and cross-functionally in fast-paced environments.
  
• Excellent written and verbal communication skills in English (Spanish is a plus).
  

*Willing to work 100% On-Site in Villalba*