Director, Operations Engineering - New Product Transition

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

 

Within the Infection Prevention Technologies (IPT) Operations team, the Director of Engineering plays a pivotal leadership role, overseeing and guiding a team of diversified engineers and engineering minded individuals who are focused on new product design transitions, encompassing prototype construction, sustaining engineering tasks, and providing support for our in-sourcing efforts across the IPT Operations division. The Director will be expected to lead, interface, and influence others in various organizations within the company. Requires working with R&D and manufacturing operations to support the strategy and development plans for a product pipeline. Relies on experience and good judgment to plan and accomplish goals. A wide degree of creativity and latitude is expected.

What You Will Do

 

• As the key liaison between R&D and Operations, facilitates communication and interaction among functional business heads to enable smooth transition for initial prototype/formulation, final manufacturing location, and scaleup as part of the NPD process.
• Provides leadership and subject matter expertise to product development team to ensure product design is manufacturable at production scale upon transfer. 
• Ensure effective development phase collaboration with R&D/Operations through final prototype/formulation release on development requirements, process scaling inputs, process equipment/fixture development, work instruction development, method development, analysis tool development, internal and supplier material specification development, release specification development, BOM development, validation planning and execution, validation reporting, and packaging and labeling development.
• Delivers critical, timely communications to the leadership. Identifies critical dependences, risks, and contingency plans. Proactively monitors progress, anticipating the effect of dependencies on schedule, cost, etc.
• Oversee direction, planning, and performance of Design Transfer team and associated personnel. Sets and communicates challenging expectations, provides support, leadership, and constructive feedback to staff members in support of meeting expectations while fostering growth and development. 
• Communicates and works with Planning to schedule pilot builds and initial production timeline.
• Develop and lead implementations of strategic business plans to leverage resources and core competencies across manufacturing facilities which may include initiatives such as in-sourcing, relocation of processes, product transfers, and development of production lines. 
• Identify, prioritize, and manage sustaining engineering projects for improvement of manufacturing processes, test methods, product specifications, process/test equipment/fixtures, analysis tools, and business systems.
• Drive prioritization, development, and implementation of basic product sustaining engineering activities; fulfill design transfer responsibilities for product sustaining engineering changes requiring product development cycle.
• Maintain core knowledge of key equipment and infrastructure and assist with the capital budgeting process for IPT Operations including planning, standardization, and execution. 
• Evaluate high profile and/or high impact strategically important engineering projects and lead or support project management activities while fostering and maintaining communication and continuity of strategic direction. 
• Foster a continuous improvement culture and support LEAN initiatives
• Must ensure that employees have a safe working environment, report all injuries, hazards, or potential hazards, follow appropriate work practices, use appropriate personal protective equipment when required, and follow established security procedures. Also responsible for ensuring that employees under their supervision receive the necessary training on all applicable safety and security work practices and procedures
• Demonstrate a commitment to patient safety and product quality by maintaining compliance with all Quality Systems requirements. Fully adhere to all applicable FDA regulations, international guidelines, and company policies at all times. Establish and promote a work environment amongst co-workers and direct reports that supports compliance with the Quality System and company policy.
• Responsible for managing the department budget and operating plans.
   

What You Need To Be Successful

 

• Bachelor’s degree in Mechanical / Electrical / Biomedical / Chemical Engineering required, Masters in Engineering Discipline, MBA preferred
• 10+ years of experience i