We're looking for a Manufacturing Engineer II to join our team at Diasorin. As a Manufacturing Engineer II, you will provide technical support for Instruments and Consumable Manufacturing operations in an ISO 13485 and FDA regulated medical device setting. You will represent Operations in design teams for new and on-market product design and development, and facilitate the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints.
Requirements
- Represent Operations in cross-functional design teams
- Assume full ownership of sustaining engineering support for on-market products
- Lead or assist in sustaining engineering initiatives to support obsolescence management
- Provide technical support for supplier issues
- Participate and drive development and implementation of process automation strategies and solutions
- Participate in the design, specification development and selection of new production equipment
- Lead and assist in engineering change control and document change control activities
- Collaborate with R&D on development and assume full design transfer ownership for Production and Market release of material specifications/drawings, manufacturing processes, repair/refurb processes, fixtures, test methods, analysis tools, and related acceptance criteria for new or on market product
- Establish and maintain standard architecture of BOMs and routings
- Collaborate with R&D on OQ process validation planning and execution
- Assume full ownership of equipment, test fixture, test method, analysis tool validation planning, execution, and reporting
- Ensure effective training of Manufacturing and Quality Control personnel for transfer of new processes
- Assist the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation
- Lead and assist in design input and implementation oversight of infrastructure improvement projects
- Provide packaging and labeling design support
- Participate in cross-functional teams supporting business process improvement and alignment initiatives
- Participate in or conduct applicable departmental, interdepartmental and intra-departmental training
- Ensure personal compliance and promote operational compliance with the Quality System and other regulations
Benefits
- Competitive salary and benefits package
- Equal opportunity employer
- Reasonable accommodations for qualified individuals with disabilities
