Manufacturing Engineer Senior 1

Knowledge / Education

• Bilingual English/Spanish – Advanced English level (written and spoken), technical writing and capable of leading presentations.
• Knowledge of applicable regulations for the medical device industry (FDA CFR 820 CGMPs, ISO 13485, etc.).
• Knowledge of statistical techniques (Sampling Plans, Hypothesis Test, Statistical Process Control {SPC}, Process Capability Studies, Design of Experiments {DOE}).
• Knowledge of Six Sigma Methodology (green belt certification) and Lean Manufacturing.
• Knowledge of dimensioning and tolerancing (ASME Y14.5).
• Proficiency in the use of MS Project.
• Knowledge of Minitab statistical software.

Additional Knowledge as a Plus

• Proficient in CAD software (AutoCad or SolidWorks) is a plus.
• Knowledge of Six Sigma Methodology (black belt certification) and Lean Manufacturing is a plus.

Job Experience

• From 4 to 7 years of experience in a manufacturing environment.
• Experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry (i.e. food, aerospace, etc.) is a plus.
• Project Management experience.

Skills / Competencies

• Capable of designing fixtures and line specific tooling (creating 3D models and technical drawings).
• Proficiency in at least one manufacturing technical field (i.e. sonic welding, pad printing, software validation, etc.) acquired through either formal training and/or work experience.
• Problem Solving: Must be able to formulate and implement mitigations or corrective actions for identified root causes.
• Decision making: Capable of making higher risk decisions within specific value streams.

Responsibilities

• Lead project management responsibilities for assigned new product launches.
• Prepare, review and/or manage project scheduling, timing, budgeting and unit cost estimations for new and/or current manufacturing projects.
• Define validation strategies and lead engineering teams for the execution of validation plans for assigned projects. Review validation protocols and reports for categories 1, 2 and 3.
• Lead the development of manufacturing process technical documentation such as Bill of Materials, Manufacturing Work Instructions, Device Master Records, Labeling Specifications, among others.
• Ensure effective communication and promote participation and involvement on project teams. 
• Support Product Launch Manager on management activities as required.

• Specify equipment and materials for new assembly processes, existing processes, or existing process changes ensuring part designs can be manufactured economically and reliably. Provide cost estimates and timing for the procurement of capital equipment.
• Directly interact and direct efforts of external resources and sub-contractors during project execution.

• Plan and review work activities and projects, monitor work flow, review and evaluate products, work methods and procedures, meet with staff to identify and resolve problems.
• Provide technical training and support to Manufacturing Engineers within categories 1, 2 and 3 as well as to Engineering Assistants and Quality Engineers.
• Be acknowledged as a subject matter expert (SME) in at least one manufacturing technical field (i.e. sonic welding, pad printing, software validation, etc.) required to providing support to the MedPlast Costa Rica campus.  
• Lead engineering teams, might have personnel reporting directly to him/her (i.e. Engineering Interns, Assistants, Technicians, etc.).
• Lead and support technicians and Manufacturing Engineers on Problem Solving and decision making.
• Act as a quality system internal and external auditor.
• Customer service: Handle customer inquiries regarding their project status. Provide assembly timing and cost estimations for RFQs.
• Perform other duties, tasks, or projects at the direction of immediate supervisor and not limited to the job category.