Job Description

This is a full-time position to work Monday to Friday from 8:00am to 5:00pm in our Heredia site located in Zona Franca Metropolitana. Remote work might be allowed based on business needs.

Main Purpose of Job: Under the direction of the Molding Engineering Manager, our Molding Engineering Superintendents are responsible for:

• Providing leadership for the molding engineering team.
• Planning and executing transfers, validations and production start-ups for new products, line extensions, and capacity increases for the injection molding area, while meeting the associated schedules and milestones.
• Supporting the transition to commercial production to ensure that quality, productivity and performance indicators of the involved areas are maintained or improved.
• Selecting and installing machinery and ancillary equipment.
• Providing technical support to the injection molding value stream and any value stream where molded parts internally produced by Viant Costa Rica are used.

Main Job Duties/Responsibilities

People

• Support, promote, and enforce Safety across the campus. Support and promote the overall EHS initiatives and programs.
• Define validation strategies and lead engineering teams for the execution of validation plans for assigned projects. Review validation protocols and reports to the Engineers.
• Prepare and present staff reports and other correspondence as appropriate and necessary.Coordinate engineering activities with different value streams.
• Lead multi-functional teams.
• Lead engineering teams. The position might have personnel reporting directly to him/her (i.e. Engineering Interns, Assistants, Technicians, etc.).
• Develop and maintain constructive-collaborative working relationships with Engineers, Program Managers, VSMs, and the entire organization.
• Lead and support Manufacturing engineers and technicians on Problem Solving and decision making.
• Perform other duties, tasks, or projects as defined by the immediate supervisor and not limited to the job category.

Quality & Operations

• Follow all GMPs and SOPs as defined by policies, practices, and procedures to ensure that Viant quality standards, FDA and ISO regulations are met.
• Provide estimates and timing for the procurement of capital equipment for further review by the corresponding approvers following the company policies.
• Lead project management responsibilities for assigned new product launches.
• Coordinate New Product/Process Introduction (NPI) planning and execution schedule in the pre-production environment and ramp-up plans with Production Planning, Value Stream Managers, and other functions.
• Lead engineering teams to identify, evaluate, develop, coordinate, validate, and implement improvement projects for current products and processes according to the applicable regulations, corporate policies, guidelines, and plant procedures.
• Troubleshoot and implement improvements to production processes using appropriate analytical methods and techniques, particularly Six Sigma methodologies.
• Seek for product and process improvement projects, and encourage these initiatives on the team.
• Promote and support key Operational Excellence programs such as 5S, Lean Six Sigma, etc., and drive improvement through shared practices and synergies with Viant Operations and VSMs.
• Lead the implementation of new extrusion and molding activities development as well as changes to existing manufacturing processes in the molding or extrusion areas.
• Prepare or review project scheduling, timing, budgeting, and unit cost estimations for new and/or current plastics processing related projects.
• Prepare and manage the budget for molding and extrusion projects.
• Specify and select equipment, molds, and materials for new molding processes, existing processes, or existing process changes ensuring part designs can be injection molded economically and reliably
• Specify, install, and develop plastics processing processes, equipment and/or support equipment for new product development, existing manufacturing process changes, replication or scale-up.
• Lead and coordinate with the appropriate departments and/or outside vendors the installation of equipment and processes by effectively analyzing required resources.
• Development of process and validation documentation. Lead the development of manufacturing process technical documentation such as Bill of Materials, Manufacturing Work Instructions, Device Master Records, Labeling Specifications, among others. Review validation protocols and reports
• Prepare, review, and/or manage project scheduling, timing, budgeting and unit cost estimations for new and/or current manufacturing projects. Communicate project schedules, monitor, evaluate results and adjust project schedules to ensure that customer requirements are met in compliance Viant’s Quality System. Write and present reports about the status of the projects and other tasks.
• Prepare plant layouts and determine material-handling systems related to the specific assigned projects.
• Support Value Stream Teams on the initial stages of the production launch of each project in terms of quality, yield, and productivity.

Knowledge / Education

• Bachelor degree in Engineering (i.e., Mechanical, Manufacturing, Industrial Engineering or science related discipline, etc.)
• 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.
• Proficient in CAD software (AutoCad or SolidWorks).
• PMI: Project Management Institute Certification is a plus.
• Knowledge of Six Sigma Methodology (black belt certification) and Lean Manufacturing is a plus.

Job Experience

• 7 Years of manufacturing experience.
• 4 Years of experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry.
• Personnel supervision is a plus.

Skills / Competencies

Good interpersonal skills, ability to work cross-functionally in a highly technical environment. Ability to work in an open, consensus-oriented team environment.

Must be able to work and effectively communicate with others orally and in writing. Good presentation skills.

Self-motivated.

Project Management. Organized and able to manage multiple tasks and priorities.

Must be able to read and understand specifications. Proficient in the interpretation of technical drawings.

Highest ethical standards and professional integrity.

Able to work independently.

Teamwork oriented.

Decision making: Must be able to quickly and independently make decisions. Capable of making higher risk decisions within specific value streams and NPI teams.

Conceptual thinker with excellent analytical skills and ability to communicate ideas across the various functions within the business. Demonstrated problem solving skills.

Problem Solving: Must be able to formulate and implement mitigations or corrective actions for identified root causes.

Strong customer orientation.

Physical / Licenses Requirements:

This position requires occasional travel, must be able to travel inside and outside the country.

Passport required.

Moderate amounts of bending and twisting.

Fit to walk between buildings of the campus.

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.