What you will do-
As the Senior Project Engineer-- Advanced Operations you will have the opportunity to work on the design transfer of new products from R&D into production. You will also be responsible for managing suppliers and working with internal teams such as Sourcing, R&D, and Operations to ensure products are developed and launched with precision.
Additional Responsibilities:
• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures
• Ensure quality of process and product as defined in the appropriate operation and material specifications
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements
• Work with quality engineers to develop component specific testing and inspection protocols
• Lead and/or participate in process review meetings
• Assist in management of contract manufacturers for multiple engineer projects
• Participate in Process Failure Mode and Effect Analysis, Control Plan, SOP and Production Part Approval Process generation associated with product transfers and launches
• Conduct supplier audits
• Ensure adherence to GMP and safety procedures
• Review and approval of validation documentation
What you need-
• Bachelor’s degree in engineering - required
• Minimum of 2 or more years of engineering experience - required
• Experience in the medical electronics / healthcare IT industry - highly preferred
• Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques - highly preferred
• Experience in R&D, new product development or process design - highly preferred
• Experience in an FDA regulated or regulated industry - highly preferred
• Knowledge of manufacturing processes, materials, product and process design - highly preferred
• Ability to read and interpret engineering drawings and can understand geometrical dimensioning and tolerancing - highly preferred
• Good instincts and sound judgement for electro-mechanical and structural design
• A professional who is organized and detail-oriented with good interpersonal communication skills
Apply Now
Apply Now