Manufacturing Engineer | Wilmington, MA
Contract (6 Months-Potential for Permanent)
Provide engineering and project management skills in support of the design and development of new processes/equipment, the scale-up and commercialization of new products, the continual improvement of existing technologies, and the optimal performance and troubleshooting of existing operations.
Responsibilities
- Provide strong engineering skills in support of the scale-up and development of new products and processes. This includes methods, procedures and specifications to ensure a timely transfer to Manufacturing.
- Provide strong engineering understanding on continual improvement teams, developing process methods, designing/sourcing equipment, conducting feasibility/developmental trials, executing validation requirements, drafting documents/specifications/drawings, and providing on-the-job training to ensure the effective transfer/start-up of new/refined products/processes.
- Manage equipment and process validations, including creation of the protocol, identification of test requirements, analysis and presentation of results, and creation of the final report, in accordance with internal procedures and external regulations.
- Utilize Lean Manufacturing principles and appropriate tools to drive continual improvement of key operational measures, e.g. yield, velocity, takt time, inventory, nonconformances, etc.
- Provide engineering support to manufacturing and QA groups to ensure that production requirements are satisfied.
- Prepare presentations and reports, as appropriate, to communicate status of engineering projects, progress towards goals and objectives, future opportunities, and current risks/alternatives to senior management.
- Support the site in developing, training, and maintaining calibration/preventative maintenance programs and manufacturing process controls.
Requirements
- 2+ years of experience in an engineering position within a medical device manufacturing organization or GMP/FDA Regulated Environment
- Working knowledge of Lean Manufacturing Principles
- Six Sigma Green Belt Certification a plus.
- Electro-mechanical systems experience is a plus
