Project Engineer
TEAM continues to grow in the oral and healthcare markets and we are seeking individuals that want to grow with us! Position details are below:
A Project Engineer is responsible for identifying, coordinating, tracking and completing the tasks necessary for achieving the larger goals of active projects. These projects can be the development or improvement of new products or processes. Also to design products and provide support for development of production equipment.
Specific Duties:
- Determine tooling requirements for new projects.
- Evaluate components for functionality and recommendation of specifications.
- Validate new tooling as ready for production.
- Identify and initiate tooling changes.
- Prepare costing and quotes for development activities.
- Coordinate manufacture and billing for development samples.
- Responsible for maintaining and complying with FDA Regulations (i.e. 21 CFR 820 – Medical Device and/or 21 CFR 210-211 – Pharmaceuticals as well as ISO standards (13485, 9001)) including adherence to Good Manufacturing Practices (GMP) and Policies such as Product Safety and PPE, Good Documentation Practices, and the related sub-parts of the appropriate Federal Codes in conjunction with TEAMs Quality Management System.
- Other duties as assigned.
Qualifications/Skills Required:
- Ability to use CAD software for product design.
- Knowledge of plastic molding and assembly methods.
- Knowledge of package methods and materials.
Education / Experience Required:
- BA/BS degree in Mechanical Engineering or relevant field, previous work experience will be considered in lieu of BA/BS
- Experience in the following areas are a plus: Product development, costing, part design, manufacturing, injection molding, statistical process control, use of CAD software.
We are an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
