Manufacturing Engineer
Nanobiosym · Cambridge, MA · 3 mo ago
EngineeringFull-time
Duties
- Cook up a production and Engineering Team in a range of manufacturing processes.
- Collaborate with team members and management to develop and enhance injection molded and assembled products and processing through numerous manufacturing stages.
- Develop and assist in the process and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that adhere to FDA regulations.
- Utilize Lean principles to devise creative, comprehensive, and practical technical solutions.
Qualifications
- An MS. or BS. in Engineering (Plastics or Mechanical preferred) or equivalent experience.
- Two to three years of experience in molding, mold-making, and tooling in a manufacturing setting.
- Two to three years of experience with CAD.
- Two to three years of experience in diverse technical, materials, manufacturing, and product design fields.
- A Six Sigma Black Belt, a bonus.
- Electromechanical experience is required.
- Understanding of statistical analysis and statistical process control.
- Recent experience with an FDA-regulated (21 CFR 820) and/or ISO 13485 environment.
- Good communication and organizational skills.