Prin Microbiologist-Steriliz
Prin Microbiologist-Steriliz
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$ 118400 - 177600
1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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.Required Knowledge and Experience:
Requires a Baccalaureate degreeand minimum of 7 years of relevant experience OR Masters degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience
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 degreeand minimum of 7 years of relevant experience OR Masters degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience
Experience with ethylene oxide sterilization process development and qualification a must. Experience with other modalities such as radiation hydrogen peroxide and/or moist heat a plus.
Knowledge of applicable sterilization standards and related microbiological methods (i.e. FDA 21 CFR 820 and various ISO standards ISO 11135 ISO 13485 ISO 11137 ISO 11138 ISO 11737 ISO 10993-7).
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Employment Type
Full-Time
