Job Board

This position is responsible for investigating, planning, and implementing complex improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, regulatory compliance, and productivity. Involved with leading projects requiring engineering team effort or a multi-discipline team effort. Responsible for complaint management including complaint review, MDR review and filing, Adverse Event reporting, metrics reporting.  Leads change review board meets, tracks and reports Corrective and Prevent Action metrics, performs Post Market Surveillance activities including PMS plans and reports and survey data collection.

 

1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

2. Provide technical assistance and leadership required to plan and implement projects to develop, install, and qualify new products, and/or new processes for manufacturing new products or for improving existing processes according to business plan objectives.

3. Provide engineering input in the design, fabrication, development, installation, validation and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment.

4. Lead cause-identification and problem-resolution for various types of production or service-related issues that arise.

5. Monitor and control programs, identify issues and ensure they are resolved.

6. Ensure proper documentation is prepared or corrected to reflect any changes implemented.

7. Research and implement cost reduction projects, lines, extensions, and/or products.

8. Provides assistance to production as required.

9. Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders.

10. Assign, delegate, and assist in the completion of engineering tasks or projects to lower level engineers.

11. Perform other duties as assigned. (rev. 4/30/12)