We anticipate the application window for this opening will close on - 30 Jun 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

This individual will work closely with program/project cross-functional teams to develop cleaning validation strategy, reviewing current design documentation, providing gap assessments and update reports as required to remediate in accordance with international standards such as ISO 17664, ANSI/AAMI ST98, ISO 15883-5, and European medical device regulations, to support the regulatory submission of implantable and non-implantable products within Medtronic’s Surgical Operating Unit (OU).

Responsibilities may include the following and other duties may be assigned.

• Participates in the creation and implementation of cleaning cycle development strategies for a variety of reusable medical devices including Class II and/or III devices, to achieve optimal solutions that satisfy timeline, cost and technical requirements as they relate to biological safety.
• Maintains an up-to-date knowledge of validation requirements, practices, and procedures.
• This role involves close collaboration with various departments to ensure compliance with regulatory and customer requirements while implementing effective cleaning strategies across the Medtronic Surgical Operating Unit. 
• Provides oversight of cleaning validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from NPD and RPE programs, and management of the revalidation within new geographies.
• Participates in the pilot program to liaise with internal resources (design, regulatory, quality, clinical and manufacturing) and with Medtronic’s Physiological Research Laboratory’s Cleanability Lab group, developing and coordinating test strategies to ensure appropriate planning and execution of required testing.
• Participates in the analysis of technical issues and the development of recommendations for project decisions and actions.
• Communicates and potentially escalates critical issues to key stakeholders that impact product design, schedule.
• Performs gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 17664, ANSI/AAMI ST98, ISO 15883-5, and European medical device regulations and standards.
• Assists in regulatory submission responses to cleaning validation questions.
• Ensures alignment of intelligent risk taking within Surgical OU.
• Influences organization excellence by recommending approaches, procedures, and work aids as they relate to biocompatibility, in compliance with applicable global regulatory requirements.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Recognized expert, managing large projects or processes.
Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.
Coaches, reviews and delegates work to lower level specialists.

Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.
May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation.
Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.
Implements solutions to problems.

Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
May negotiate with others to reach understanding or agreement, and influence decision-making.

Leadership and