Process Engineer

Essential functions: 

1. Ensure that the production and/or service of products are maintained at the rate and quality levels assigned as required by applicable quality system and regulatory requirements. 

2. Review and approve changes made to products that may impact production or service lines. 

3. Continually look for ways to reduce the cost of the manufacturing and/or service by implementing innovative solutions and streamlining processes. 

4. Generate manufacturing and/or process instructions. 

5. Analyze process metrics and institute changes to maintain quality levels. 

6. Provide project management direction and/or project support as a member of a project team. 

7. May develop, implement and maintain validation process plans. 

8. May provide mechanical, pneumatic and electrical support for test fixtures and automated/semi-automated test systems. 

Education required/ preferred: 

B.S. in a Technical field from an accredited four-year college or university or an equivalent combination of education and experience. 

Experience:

4-6 years of related experience with increased responsibility in Manufacturing and or service of electronic /electromechanical medical devices. 

Preferred Skills/Qualifications: 

Knowledge of medical device regulatory requirements. Experience with mechanical, electrical, electronics, software, and/or instrumentation technologies. Must have good troubleshooting and time management skills. 

Skills/Competencies:

Excellent oral and written communication skills. MSWord, MS Project, Excel, and statistical software. Knowledge of product structures and manufacturing processes. 

Other Skills:

Lean Manufacturing, Six Sigma, validation/qualification (IQ, OQ, PQ) experience, CAD skills, able to read technical drawing; ability to travel occasionally. 

To discuss more about this job opportunity feel free to reach me.

Sagar.rathore

630-485-2166

Sagar.rathore (at) Collabera.com