Location: Anasco, PR

Responsibilities:

• Capable of preparing User Requirements Specifications for process equipment.
• Prepare contractors bidding package for construction and installation of equipment.
• Guide contractors to comply with technical specifications.
• Interact with internal functions, like EHS, QA, Validations to convert their inputs into project actions.
• Coordinate project activities across the siteKeep project plan up to date throughout the project lifecycle.
• Prepare updates for project forums.
• Preferable a BSME but a technical resource with experience on industrial equipment from other engineering disciplines can be a fit as well.
• Develops, coordinates, and implements (leads) the development of processes, process improvements, introduction/transfer of new processes, scrap reduction, capacity increase, introduction of new technology, production support, cost improvements projects, CPA projects and plant construction projects, among others.
• Coordinates plant activities related to Design Control, assuring that these are carried out timely, efficiently and in compliance with plant procedures and regulatory agencies.
• Evaluates and assures completeness of Design Control Procedures for projects under his/her responsibility.
• Represents the Facilities Engineering team in internal/external audits related to construction related Design Control.
• Uses Project Management and Lean/Six Sigma tools to manage major plant projects, assuring that time, cost and quality requirements are met.
• Manages the plant labeling changes process.
• Develops, maintains, and improves manufacturing methods of current product lines, utilizing knowledge of product design materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and Quality Control standards to assure a continuous supply of high quality products at the lowest cost.
• Directly participates in plant and customer satisfaction cost saving projects, implementation of equipment, standards, and specifications and customer satisfaction assurance.
• Plans, designs, and coordinates the integration of machinery and equipment into the manufacturing process and its qualification/validation, applying knowledge of engineering and programming, using computers, precision measuring instruments, and drafting tools.
• Evaluates products structure and develop time and scrap standards.
• Renders support to other departments in the matters of manufacturing technology and trouble shooting.
• Negotiates and approves the fulfillment of contract specifications. Implements trainings and encourages employees professional development and accomplishment of their career path.
• Maintains a visible commitment to Quality Improvement.

Requirerments:

• B.S. is required. Concentration in Engineering.
• A minimum of 4-6 years practical experience in a manufacturing environment, preferably the medical device industry.
• Knowledge, skills, and abilities: Knowledge of SPC, Lean/Six Sigma, JIT, TQC, GMP, QLP and Design Control applications is preferred.
• Strong construction/process/material validations knowledge is preferred.
• Strong Project management Skills is preferred.
• Knowledge of ergonomics is preferred.
• Knowledge of OSHA and FDA regulations is preferred.
• Computer skills is required. Knowledge of Project Management Tools (e.g. Microsoft Project) is preferred.
• Knowledge of project management, cost control, and development of guidelines, trainings, and programs is preferred.
• Excellent interpersonal and communication skill at all levels.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 26.30/hr.