Job Summary

The Sterilization Engineer will lead resolution of challenging process engineering problems within Sterilization on diverse scopes specific to medical devices. Independently leads the design and development of equipment and instruments for use in complex assembly and testing of medical devices. Works independently to identify, design and develop innovative solutions for implementation into irradiator and processes used in volume manufacturing systems. Exercises judgment and define methods and criteria in conducting process engineering experiments and reports results. Develop networks with internal/external working relationships in area of expertise.

Responsibilities:

• Maintain, develop and validate advanced manufacturing processes and equipment, in accordance with applicable medical regulatory standards. 25%
• Perform process and equipment improvement and optimization.
• Generate reports on engineering data, analysis and results.
• Lead and influence cross functional teams for the implementation into pilot and volume manufacturing systems. 25%
• Develop significant process/product specifications, conduct pFMEAs, DOEs, author characterization and validation protocol, lead execution and author reports and other associated documentation following design control requirements. 25%
• Communicate effectively and participate in cross functional development teams.
• Conduct or participate in technical design reviews of process equipment and product design and requirements documents. 25%
• Write and submit Engineering Change Orders, as required.
• Ensure that processes and equipment meet all applicable standards.

Required Qualifications

• Bachelor's degree in engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred) or an equivalent combination of education and work experience
• Minimum of 6 years of related work experience
• Solid knowledge of general Engineering principles.
• Good knowledge of design controls and regulations for medical device development, (ISO134851, ISO13485, FDA).
• Strong technical experience in mechanical or chemical engineering with excellent written and verbal communication skills are essential.
  Strong understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips
• Experience in all of the following: performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis working in a development environment with a disciplined process/product development process.
• Writing process/product requirements and design specifications.
• Working on a development team with an emphasis on minimizing time to market.
• Design for manufacturing low cost, high volume electronic products. development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.
• Working in cross functional team environments is required.

Preferred Qualifications

• Solid knowledge of general sterilization principles
• Good knowledge of validation and regulations for medical device development, (ISO134851, ISO13485, FDA).
• Strong understanding of irradiation sterilization processes and materials used in and manufacturing of medical devices, particularly diabetes strips