Manufacturing Engineer

hace 4 semanas

Añasco, Puerto Rico Eqval A tiempo completo

EQVAL Consulting Group, Inc.  is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).
We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.
Project Focus: The Manufacturing Engineer will support design changes impacting operations, manufacturing, launch readiness, and product stability.
This role provides technical expertise and leadership in medical device life cycle management, supplier change management, cost of goods (COGs), process development, validation, and production stability.
Responsibilities: Collaborate on cross-functional project teams with departments such as R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and enhance surgical products.
Review and update product specifications and drawings for legacy products; define acceptance criteria for product specifications.
Develop detailed project plans for qualifications, ensuring proper identification of team resources, accountability for deliverables, and timely milestone completion.
Provide engineering expertise to resolve design, manufacturing, and quality-related issues impacting existing products.
Generate and issue change control documentation to address supplier-driven changes in components and raw materials, following applicable procedures.
Adjust priorities and tasks in response to shifting business needs and project demands.
Lead process improvement initiatives for CSS products, both internally and with external suppliers, focusing on manufacturing efficiencies and product quality.
Lead projects aimed at improving existing products and manufacturing processes while ensuring compliance with regulatory and quality standards.
Support the selection, validation, and implementation of replacement materials, including polymers, metals, and adhesives, for CSS applications.
Lead and support corrective actions across the production process, ensuring improvements are executed and sustained.
Qualifications: Education: BS in Engineering (Mechanical, Industrial, Electrical, Chemical, or Biomedical preferred), or a related field.
A Professional Engineer License is a plus.
Experience in Validations: Strong experience with validations, including manufacturing equipment, processes, stability/aging studies, and process controls.
Experience: A minimum of 4-6 years in the medical device and/or pharmaceutical manufacturing environment, with exposure to controlled, regulated industries.
Regulatory Knowledge: In-depth understanding of FDA, OSHA, EPA, GMP, and ISO standards and requirements.
Process Improvement Expertise: Strong foundation in Organizational Excellence and Lean/Six Sigma methodologies.
Certification in Lean/Six Sigma (Green or Black Belt) is a plus.
Leadership Skills: Proven ability to lead complex projects and cross-functional teams while providing departmental technical leadership.
Communication Skills: Exceptional communication skills with a demonstrated track record of cross-functional collaboration.
Strategic Thinking: Ability to think critically and strategically to address challenges and deliver results.
Technical Documentation: Proficient in developing technical documentation, including Change Controls, Validation Plans, Validation Protocols, Technical Reports, SOPs, and other regulatory or quality-related documents.
Benefits: Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Professional development assistance Referral program Vision insurance Schedule: 8 hour shift Day shift Monday to Friday   Powered by JazzHR

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