Product Development Engineer

Responsibilities

• Develop a Manufacturing Security Program for the Interventional Segment of client.
• Develop architecture and high level designs standards.
• Process and procedures to implement and operationalize.
• Define processes for the on-going management and maintenance of solutions.
• Define metrics to demonstrate control effectiveness.
• Help coordinate requirements gathering, review of design, and obtain approval from plant engineering across client sites.
• Works with project team to identify, design, implement and sustain new products/processes.
• Aids in establishing the need and costs of new or improved systems at the Mannford facility.
• Acts as project leader and/or team player on various Mannford facility projects.
• Teams on projects such as installation of new equipment/process; new or improved product lines; process, software and packaging validation.
• Communicates project status information to all team members, as well as engineering, manufacturing and general office management.
• Independently tests, analyzes and solves technical problems.
• Applies statistical techniques and utilizes design of experiments.
• Studies equipment utilization and recommends the use or replacement of existing equipment with a vision to optimize the Company's economics.
• Reduces standard product cost through optimization of processes and/or equipment where applicable.
• Advises management of potential problem areas.
• Develops new documentation and modifies existing documentation per project requirements.
• Provides technical engineering support for production via documentation and hands-on training to ensure quality production output.
• Works closely with Central Documentation to ensure a smooth transition and document trail from design to manufacturing.
• May lead and coordinate activities of other engineering employees.

Qualifications & Skills

• BS degree in Mechanical, Industrial, Electrical, Chemical, Biomedical Engineering or 1-2 years of related work experience in medical device industry.
• Excellent written and oral communication, presentation, and interpersonal skills.
• Must be computer literate.
• Knowledge of Good Documentation Practices is necessary.
• Must be able to organize and prioritize work with limited guidance.