Senior Engineer, Medical Devices

Summary:

• The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. This engineer would have the ability to read and interpret drawings.

Job Responsibilities:

• Execute production builds both on live WO and under protocols, as needed.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
• Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
• Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
• Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
• Evaluate data and write reports to validate or indicate deviations from existing standards.

Software Skills:

• Ignite PLM (Team center)
• Previous experience with computer applications and software such as MS Project and Excel.

Skills:

• Previous experience working on valves or other cardiovascular medical devices
• Driven product execution and finalizing builds for market release (and lead these efforts)
• Skilled in report documentation authoring and release
• Strong communication skills both verbally and written is REQUIRED, this role will have a lot of touchpoints with onsite labs and other facilities driving production
• Lead change requests, build coordination, and documentation of class II or III medical devices

Education/Experience:

• Bachelor's degree in engineering required.
• 5-7 years experience required.