Mechanical Engineer medical Device Industry experience_

Job Title

Relocation is required. Thanks.

• Mechanical Engineering Degree - MUST
• 8 - 10 years of Medical Device industry experience - MUST
• Experience in Product Design and Manufacturing - excellent Manufacturing experience-Must

o DOE. o Process Development. o Develop manufacturing tool/fixture/test equipment. o Equipment IQ (Write, Execute, and Complete). o Knowledgeable of Component and Process Qualification and Validation (Write, Execute and Complete). o Knowledge/Experience create test protocol, execute, and complete protocol with summary report, related to component, design and process changes. o Create and Execute FMEA/PFMEA. o Have first-hand knowledge/experience in create process flow map, develop project plan using MS Project Gantt's, Organize and Manage individual project plan/schedule.

o Proficient using CAD and Solid model software to create 2D/3D mechanical component drawing/model and Sub/Final Assembly drawing. o Proficient read and create mechanical drawing. o Must have strong written and verbal communication skill. o Must take ownership and accountability to manage and drive own individual project. o Good technical analytical skill and logical thinking.

Good to have:
· MS Word, Excel.
· Knowledgeable of New Product Development process.
· Understanding of FDA and Compliance regulations.