Molding Engineering Superintendent

"X" denotes the duty applies to the category; "S" denotes duty supported by upstream level

Duty/Responsibility

Engineering

Superintendent

People

• Support, promote, and enforce Safety across the campus. Support and promote the overall EHS initiatives and programs. 

S

• Define validation strategies and lead engineering teams for the execution of validation plans for assigned projects. Review validation protocols and reports to the Engineers.

X

• Prepare and present staff reports and other correspondence as appropriate and necessary.

X

• Coordinate engineering activities with different value streams.

S

• Lead multi-functional teams.

X

• Lead engineering teams. The position might have personnel reporting directly to him/her (i.e. Engineering Interns, Assistants, Technicians, etc.).

X

• Develop and maintain constructive-collaborative working relationships with Engineers, Program Managers, VSMs, and the entire organization.

S

• Lead and support Manufacturing engineers and technicians on Problem Solving and decision making.

X

• Perform other duties, tasks, or projects as defined by the immediate supervisor and not limited to the job category.

X

Quality & Operations

• Follow all GMPs and SOPs as defined by Viant’s policies, practices, and procedures to ensure that Viant quality standards, FDA and ISO regulations are met.

X

• Provide estimates and timing for the procurement of capital equipment for further review by the corresponding approvers following the company policies.

S

• 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.

S

• 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.

S

• Troubleshoot and implement improvements to production processes using appropriate analytical methods and techniques, particularly Six Sigma methodologies.

X

• Seek for product and process improvement projects, and encourage these initiatives on the team.

S

• 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.

S

• Lead the implementation of new extrusion and molding activities development as well as changes to existing manufacturing processes in the molding or extrusion areas.

X

• Prepare or review project scheduling, timing, budgeting, and unit cost estimations for new and/or current plastics processing related projects.

S

• Prepare and manage the budget for molding and extrusion projects.

S

• 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

X

• Specify, install, and develop plastics processing processes, equipment and/or support equipment for new product development, existing manufacturing process changes, replication or scale-up.

X

• Lead and coordinate with the appropriate departments and/or outside vendors the installation of equipment and processes by effectively analyzing required resources.

S

• 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

X

• 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.

S

• Prepare plant layouts and determine material-handling systems related to the specific assigned projects.

X

• Support Value Stream Teams on the initial stages of the production launch of each project in terms of quality, yield, and productivity.

S

B:  Basic; I: Intermediate; A: Advanced; P: Plus

Requirement

Engineering

Superintendent

• Bachelor degree in Engineering (i.e., Mechanical, Manufacturing, Industrial Engineering or science related discipline, etc.)[1]

A

• Bilingual English/Spanish – Advanced English level (written and spoken), technical writing, and capable of leading presentations.

A

• Knowledge of applicable regulations for the medical device industry (FDA CFR 820 CGMPs, ISO 13485, etc.).

I

• Knowledge of statistical techniques (Sampling Plans, Hypothesis Test, Statistical Process Control {SPC}, Process Capability Studies, Design of Experiments {DOE}).

I

• Knowledge of Six Sigma Methodology (green belt certification) and Lean Manufacturing.

I

• Knowledge of dimensioning and tolerancing (ASME Y14.5).

B

• Proficiency in the use of MS Project.

I

• Knowledge of Minitab statistical software.

I

• PMI: Project Management Institute Certification desired

P

• Proficient in CAD software (AutoCad or SolidWorks).

B

• Knowledge of Six Sigma Methodology (black belt certification) and Lean Manufacturing.

P

B:  Basic; I: Intermediate; A: Advanced; P: Plus or # of years

Requirement

Engineering

Superintendent

• Years of manufacturing experience.

7

• Years of experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry.

4

• Personnel supervision.

P

B:  Basic; I: Intermediate; A: Advanced; P: Plus

Requirement

Engineering

Superintendent

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

A

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

A

• Self-motivated.

A

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

I

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

A

• Highest ethical standards and professional integrity.

A

• Able to work independently.

A

• Teamwork oriented.

A

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

I

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

I

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

I

• Strong customer orientation.

A