Job Summary:
Responsible for supporting manufacturing operations and leading engineering continuous improvement initiatives for existing molding, automation, and assembly production lines. Work with the Operations and Quality teams to meet or exceed customer requirements on both new and existing manufacturing lines.
Essential Duties and Responsibilities:
- Become subject matter expert for processes and equipment to support manufacturing operations through project improvements, quality investigations, root cause analysis, CAPAs, and technical escalations.
- Under guidance and leadership, works with internal and external team resources to:
- Develop, execute and document project assignments in compliance with committed timelines and project goals, and established governance policies and procedures.
- Actively support proprietary program initiatives with direct customer interactions as warranted by project assignments
- Ensure technical and customer requirements for assigned projects are achieved.
- Ensure that all required documentation deliverables are satisfied and delivered.
- Understand key business drivers and follow applicable West project management process & methods in execution of assigned tasks
- Maintain clear communication paths with stakeholders
- Draft required quality records and project management documents associated with assigned projects.
- Assist with the installation and validation of new equipment/process through SAT/IQ/OQ/PQ
- Ability to lead, execute and deliver projects within value stream
- Good project management skills, providing routine project review updates to direct leadership, while working on solutions and contingencies for any deviations from plan.
- Good problem-solving skills, analyzing possible solutions using standard methodologies, procedures, experience, judgment and precedents
- Impacts quality of own work and the work of others on the team; works within guidelines and policies
- Promote and support site initiatives including safety programs, lean initiatives, training programs, and consistently interpret & apply all policies, practices and procedures among plant employees.
- Performs other duties as assigned based on business needs.
Basic Qualifications:
- Bachelor’s degree in Engineering, or equivalent technical degree
- 3 – 5 Years of manufacturing environment experience
Preferred Knowledge, Skills and Abilities:
- Medical device development and manufacturing background preferred
- Knowledge of manufacturing processes, workflows, basic electrical / automation equipment and industrial techniques.
- Knowledge of Injection Molding, automation, and manually assembly would be an advantage
- Must have effective problem solving and interpersonal skills.
- Must have knowledge of sound engineering principles and practice.
- Must possess the ability to plan work and supervise others, as needed.
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
Travel Requirements:
- Must be able to travel up to 10% of the time
Physical and Mental Requirements:
- Must be able to perform job duties as required with limited physical demands within clean room manufacturing requirement.
- Medical Device manufacturing requires strict adherence to standards.
- Working environment is a manufacturing facility, which houses plastic injection molding machines.
- Must tolerate fumes and particulate generated from various plastics.
- Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition.
- Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
- Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
- May sit or stand for extended periods of time.
- Must transport oneself to and from other areas of the facility and travel to other divisions when necessary.
- Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.