Vacancy expired!
- Responsible for the following project inputs:
- Feasibility builds, documentation, and testing,
- Equipment selection,
- Process development and documentation,
- Device Verification samples and testing,
- Operator training,
- Process Failure Mode Effects Analysis,
- Clinical builds,
- Process Validation
- Involvement in the design, development, and validation requirements of projects, including:
- Product design and specification creation, including mechanical and electrical components, assemblies, and packaging,
- Materials sourcing and device prototyping,
- Manufacturing transfer and support of existing product lines as applicable.
- BS in Engineering (Mechanical preferred)
- 5+ years experience in medical devices (active implantable), not all required to be in process development
- Solid understanding of engineering concepts and principles
- Able to develop validation protocols and synthesize data to write test reports based on observed data, relevant test standards and general engineering knowledge
- Familiarity with statistical analyses; DOE and Gage R&R execution
- Familiarity with FDA, ISO and EN Standards as they apply to medical devices
- Good understanding of Quality Management Systems and standard operating procedures
- Ability to travel up to 10%
- ID: #50013453
- State: Minnesota Minneapolis / st paul 55415 Minneapolis / st paul USA
- City: Minneapolis / st paul
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2023-05-28
- Deadline: 2023-07-26
- Category: Et cetera