Manufacturing Engineer II

• Represent Operations in cross-functional design teams to deliver transfer of design changes or new product introduction of instruments and consumables through product development, validation, and market release phases
• Assume full ownership of sustaining engineering support for on-market products
• Lead or assist in sustaining engineering initiatives to support obsolescence management
• Lead or assist in product, supplier, and process sustaining engineering initiatives to improve quality, compliance, safety, efficiency, reliability, cost, and scale throughput
• 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, such as, test fixtures, manufacturing aids, and automation equipment
• includes scale-up of existing processes and development of new processes
• Lead and assist in engineering change control and document change control activities
• participate in change control reviews
• 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, work instructions and related acceptance criteria for new or on market product
• Establish and maintain standard architecture of BOMs and routings
• interface with Cost Accounting for new or on-market product COGs roll-up
• Collaborate with R&D on OQ process validation planning and execution
• Assume full ownership of PQ process validation planning, execution, and reporting
• Assume full ownership of equipment, test fixture, test method, analysis tool validation planning, execution, and reporting
• collaborate with R&D as required
• 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

• Bachelor’s degree in Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering
• 3-5 years of experience in process improvement and sustaining engineering in a ISO 13485 and/or FDA regulated Life Sciences, Medical Device, or Medical Technology industry
• Thourogh knowledge of ISO 13485 and FDA Quality System requirements
• Profeciency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control
• Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
• Proven results through application of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments
• Excellent problem-solving skills and attention to detail
• Strong communication and teamwork skills
• Experience with SCADA systems and industrial networks

Receive a competitive salary and benefits package as you grow your career at Diasorin