Manufacturing Engineer - Level I

• Represent Operations in design teams
• fulfill design transfer responsibilities for new and on market 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
• 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
• 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.
• 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.
• Ensure compliance to NFPA, OSHA, lock-out, and other applicable safety standards.

• Bachelor's Degree Bachelors of Science in the field of Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering.
• 5+ Years Experience and technical leadership supporting process improvement and sustaining engineering in a ISO 13485 and/or FDA regulated Life Sciences, Medical Device, or Medical Technology industry.
• 1+ Years Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities
• Thorough knowledge of ISO 13485 and FDA Quality System requirements
• Knowledge of Enterprise Resource Planning, including applied knowledge of engineering functionality
• Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control
• Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
• 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
• Mathematics and statistics aptitude.
• Data analysis and technical writing aptitude.
• Excellent oral and written communication skills.
• Proficient in Microsoft Word, Excel, and PowerPoint programs.
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines

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