Senior Product Engineer, Sustaining

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

The Senior Sustaining Engineer is responsible for all design aspects of our products after a product is released for production. Responsibilities include design and design control for product changes that result from supplier changes, quality improvements, new or changing regulations and standards, performance improvements, and cost reductions. Projects must be completed accurately, within compliance, and quickly to avoid stock-outs. The position should also actively seek areas for improvement in internal processes and create innovative solutions in both product design and process flow. The engineer is responsible for assisting in CAPAS, NCR’s, and complaint investigations. 

What You'll do as a Senior Sustaining Engineer

• Work within cross-functional team structure to ensure projects maintain momentum, meet timelines, and collective good decisions are made regarding design, materials, manufacturing, quality, costs, regulatory compliance, and intellectual property.
• Responsible for product design including CAD design, prototyping, and design control documentation including input/output specifications and risk management files.  Engineer is responsible for writing product verification and validation protocols and leading various teams in product risk assessments (hFMEA); maintain design history file documents in accordance with the Quality Management System
• Work independently or with other engineers as well as clinicians and marketing representatives to review design ideas and prototypes; proactively coordinate, direct, and perform design activities related to GI endoscopic devices and accessories that were previously released for manufacturing.
• Ability to determine engineering related design control requirements when assigned a project/problem with regards to a currently marketed device. Understands project risks and develops plans and contingencies to mitigate failures.
• Effectively manages multiple projects and/or responsibilities concurrently, while adapting to changing needs and priorities. Prioritizes tasks appropriately and delivers on project deliverables and milestones. Maintains a sense of urgency.
• Work with NPD teams to ensure smooth Design Transfer of New Products into production Work with multiple different groups of people to ensure minimal risk to the production floor (including stock-outs) when introducing a change.
• Demonstrates technical knowledge in areas such as materials, plastics, molding, welding, component assembly, and packaging, and effectively utilizes knowledge to design and support the technical needs of the organization.
• Communicates clearly and effectively, especially regarding key changes to project scope, quality, timeline, and expenses. Presents project updates to technical and non-technical audiences effectively (meetings, presentations, etc.).
• Actively seeks areas for improvement in internal processes and creates innovative solutions in both product design and process flow.
• Leads or assists with resolution and mitigation of CAPAS, NCR’s, and complaints.
• Mentors team members on timely task completion and guides others in decision-making and breaking down complex tasks.
• Generates detailed, high quality technical documentation to capture and communicate designs.

The Experience, Abilities and Skills Needed

• Bachelor's Degree in Engineering and 5+ years of experience
• 5+ years of experience in Design control, Mechanical Design and Solidworks
• 4+ years of experience of the following
  • Understanding of medical device regulatory, document, and quality control issues 
  • Knowledge of IEC and ISO standards surrounding medical electrical equipment, quality systems, and risk management requirements
  • Proven ability to innovate with a history of successful new product releases (medical devices a plus). Use of a customer driven approach to problem solving and product design is desired 
• Excellent engineering and organization skills and ability to work independently or within groups and strong interpersonal skills
• Excellent verbal and written communication skills. Proven ability to communicate clearly and effectively with cross-functional groups across the organization
• Ability to accurately obtain, record, and communicate test data to non-technical personnel
• Must be able to travel domestically to observe clinical usage, attend conferences, and participate in animal or bench tests
• Strong project management skills & a solid understanding of project management methodologies, tools, and techniques is required
• Strong proficiency w