Microbiologist II - Cirtec Medical Corporation

About us:

For over three decades, Cirtec Medical has been a leading provider of vertically integrated solutions for complex Class II and III medical devices. We specialize in providing comprehensive solutions from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!

Job Summary

This position is responsible for overseeing and administering microbiology activities within the Quality System for Cirtec cleanrooms, water systems, and sterilization. This includes specifying requirements, validation activities, establishing and maintaining controls, monitoring, and reporting. The incumbent will ensure compliance with global quality/regulatory requirements, internal requirements, and applicable standards.

Key Responsibilities

• Develop, implement, and maintain required Regulatory compliance with all regulatory agencies, including, but not limited to, U.S. FDA, EU/ISO, Canadian, Asia-Pacific and Latin America regulations.
• Maintaining current working knowledge of FDA and global regulatory requirements, and keep Management appraised of new developments and potential impacts to our customers and the organization.
• Promotes organization to customers and fosters customer/industry relations.
• Ensures effective analysis and reporting of sterilization data. Including the development strategies to address problematic test observations and deficiencies.
• Compiles and analyzes trend data appropriate for continuous improvement and monitoring of product sterility, DI water systems, and clean rooms.
• Writes sterilization protocols, reports, and adoptions appropriate for products in compliance with the current regulations.
• As a team member, coordinates project activities for new product and product revision designs to analyze possible impacts on sterilization properties.
• Manages sterilization and environmental monitoring testing including preparing test samples, scheduling, coordinating with outside facilities, planning, and purchasing as needed.
• Authors technical documents that effectively interpret and present data and provide appropriate rationale to support conclusions regarding sterilization and environmental controls.
• Provides input to QC and Manufacturing regarding product sterility levels and provides feedback to manufacturing to ensure basic understanding of the possible causes of sterility testing / monitoring discrepancies.
• Performs internal assessments on documents and practices to ensure continuing compliance with current standards for medical device manufacturing regulations and Company SOPs as related to product sterility and controlled area environmental controls.
• Determines corrective action and performs re-assessments in response to sterilization or environmental issues and planned changes.
• Assists in developing sterilization and environmental specifications.
• Remains informed about current standards, regulations, engineering and material trends regarding sterilization and environmental control by reviewing current literature for technological application, and appropriate coursework.
• Research ideas for improvements to SOPs to improve compliance, streamline operations, and/or save cost.
• Reviews appropriate technical literature for necessary background on specific assignments.
• Performs duties in compliance with the Quality System.
• Other responsibilities and duties as assigned.
• Travel requirement: 10%
• Complies with company, quality and safety standards, policies, and procedures
• An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

This position is an onsite role, located in Brooklyn Park, MN

Must Have:

• Bachelor of Science degree in Engineering or associated fields, Microbiology preferred.
• 5+ years’ experience in microbiology roles in medical devices or pharmaceutical.
• Knowledge and experience with external standards: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to environmental systems, cleanrooms, DI water, and sterilization
• Ability to present in audits by customers, certification bodies, and regulatory agencies.
• Strong verbal communication. Ability to present technical information to various levels of management in a manner that is easily understood.
• Strong written communication skills including ability to write protocols and reports for engineering approval.
• Strong math & analytical skills.
• Very good working knowledge of statistics.
• Very good problem-solving and organizational skills.
• Ability to apply detailed product or process knowledge to solve problems.
• Ability to apply the scientific method.
• Very good troubleshooting skills on equipment or processes.
• Strong interpersonal skills, demonstrated ability to interface on project teams as an effective team member
• Demonstrated ability to coordinate complex activities
• Proficiency with personal computer software including word processing, spreadsheet, and statistical programs
• Takes initiative in all areas of responsibility and anticipates needs and potential problems.
• Must be able to read, write and speak fluent English
• Ability to effectively train others.

Working Environment

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.