Manufacturing Engineer

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.
Lead process improvement initiatives with internal and external suppliers, focusing on manufacturing efficiencies and product quality.
Support the selection, validation, and implementation of replacement materials, including polymers, metals, and adhesives.
Lead and support corrective actions across the production process, ensuring improvements are executed and sustained.
Qualifications: BS in Engineering (Mechanical, Industrial, Chemical, or Biomedical preferred).
Three (3) years or more of knowledge and experience in cGMP and ISO 13485 in a Medical Devices manufacturing environment.
One to five (1-3) years of equipment qualification and process validation knowledge (IQ, OQ, PQ protocols generation and execution, deviations, and reports generation).
Knowledge on statistical data management and analysis (including the usage of statistical tools, i.e, Minitab) Knowledge and skills (1-3 years) in diverse areas such as: Investigations (NCRs, Complaints, CAPA), Lean Manufacturing and Six Sigma Tools, Time Management, and Project Management.
Highly Motivated, Self-Starter and Multitask Oriented.
Computer literate (Word, Excel, Power Point, Minitab).
Excellent communicator (spoken, written) in both, English and Spanish.
Job Types: Full-time, Contract 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 Work Location: In person Powered by JazzHR