We're a recruiting firm focused on your success! Our client is an engineering firm in the Brockton, MA area and is looking for a Sr. Injection Molding Engineer to join their team and lead an effort against COVID-19 by developing, implementing and maintaining a production line related to testing.
What you will be doing:
- Collaborating with team to develop projects and process validation of new high-quality products.
- Using Lean, Design for Reliability and Manufacturing (DRM), and Conditions of Satisfaction (COS) principles to create solutions.
- Develops and implements validation protocols (IQ/OQ/PQ) that comply with FDA regulations.
- Complying to FDA regulation through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation protocols.
- Solving product quality issues through root-cause/ RISK analysis and creating specification documents.
- Collaborating with others, such as Quality Assurance, Sales, and customers, to achieve high quality results.
- Direct the specification, fabrication, and implementation of tooling and production aids
- Looking for ways to improve processes through automation, standardization, and equipment upgrade.
What you will be doing:
- Knowledge of process development concerning microfluidic parts forming.
- Experience supporting Research and Development projects from start to finish.
- M.S. in Plastics or Mechanical Engineering Degree (Six Sigma Black Belt preferred)
- Experience in molding / manufacturing / materials / product design environment (7+ years).
- Knowledge of micro injection molding ISO 13485 environment in medical technology.
- Experience with FDA regulations concerning medical device development (21 CFR Part 820)
What you will get:
- Competitive compensation.
- Paid relocation (if needed)
- Experience leading the fight against current pandemic.
- Full benefits + PTO.