The Engineer II will be responsible for day-to-day production support, developing, maintaining and improving production processes. Engineers at this level must have prior relevant experience in the medical device industry and are expected to be able to work under general supervision on moderately complex engineering assignments. This role is responsible for improving manufacturing quality, lead time and cost through active problem solving, developing solutions and implementing process changes in accordance with the quality system.

Essential Duties and Responsibilities:

• Apply engineering skills to create manufacturing processes or improved established processes.

• Develop process characterizations (DOEs), qualifications (TQ/IQ/OQ/PQ/TMV) and PFMEAs.

• Prepare manufacturing work instructions and provide training as required.

• Responsible for evaluation and analysis of data, lead investigation and documentation of all validation deviations and determine impact on the validations.

• May incorporate inspection and test requirements into the production plan.

• Perform data analysis and apply statistical techniques to optimize and correct established manufacturing processes as directed. Collect, analyze, & report process data.

• Provide technical and engineering support in a manufacturing area.

• Evaluate performance of equipment to verify efficiency and investigate and initiate corrective action of problems and deficiencies to ensure product quality.

• Develop manufacturing processes that are applicable to statistical process control and may develop those techniques.

• Troubleshoot any production problems; assure that equipment and facilities are properly maintained for efficient production; report any process or equipment problems to manufacturing engineering management.

• Provide technical and manufacturing engineering support to sustain current production through day-to-day support.

• Assure compliance with all regulations and good manufacturing practices.

• Perform other duties as assigned.

• Bachelor’s Degree or higher in Plastics Engineering, Mechanical Engineering, Manufacturing Engineering or other engineering discipline.
• 0 years of experience required.
• Proactive learner.
• Strong knowledge of polymer materials and their properties.
• Must have good interpersonal and communication skills.
• Proficient in CAD, Word, Excel, and PowerPoint.

Preferred Job Qualifications:

• Knowledge of scientific molding principles.
• Certification in plastics engineering or related field.

Physical / Mental Demands:

· Working conditions are normal for an office environment.

· Work may require weekend and evening work.

· Work may require travel.

· Physical activity includes sitting, walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 pounds.

· Work under stress in a fast-paced environment.

· Must be alert, able to concentrate, and use good judgment.