We anticipate the application window for this opening will close on - 15 Oct 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

The Principal Microbiologist - Sterilization at Medtronic is responsible for projects related to the design, development, and qualification of terminal sterilization processes for medical devices. This role involves ensuring compliance with various government and industry regulations, and leveraging microbiological test methods for sterilization qualifications.

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

• Drive development, qualification, implementation and optimization of terminal sterilization processes (Ethylene Oxide, Steam, Radiation and other modalities)

• Work closely with contract sterilizers, laboratories, operations, sourcing, R&D & regulatory to ensure coordination of activities related to sterilization processes.

• Support on-going maintenance of the sterility assurance program including performing gap assessments for compliance and alignment with industry standards; driving change, improvements and best practices.

• Support sterility assurance program with periodic reviews of environmental monitoring, bioburden, product adoption, supplier changes, metrics and requalification activities as assigned.

• Work with internal and contract laboratories to develop and qualify microbiological test methods supporting device sterility assurance.

• Support and perform supplier audits including contract laboratories, contract manufacurers and microbiology laboratories.

• Responsible for sterility assurance related nonconformances, deviations, and CAPA investigations. Perform SME technical evaluations of abnormalities in sterilization processing and batch records for product release.

• Authors qualification and technical documentation related to area of expertise

• Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.

• Supports internal and external audits supporting regulatory compliance as Sterility Assurance SME

• Trains, mentors, and develops Sterility Assurance colleagues

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 Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience: Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relev