R&D Sterile Disposables Senior Engineer (Microbiology & Biocompatibility)

At Bayer, we're visionaries driven to solve the world's toughest challenges and strive for a world where 'Health for all, Hunger for none' is no longer a dream, but a reality.

As a Senior Engineer in our R&D Sterile Disposables team, you will be responsible for designing, planning, executing, documenting, commissioning, and handing over specific technical work packages. You will focus on microbiology, chemistry, sterile disposable devices, and verification and validation testing for Radiology medical device programs.

Key Responsibilities:

• Balance multiple concurrent projects and prioritize tasks effectively
• Develop practical and creative solutions to technical problems
• Support policy and procedure development, and apply relevant regulations and standards
• Apply knowledge of microbiology, chemistry, and engineering to develop, validate, and implement new test methods
• Collaborate with cross-functional stakeholders to support medical device compliance

Technical Scope:

• Support reprocessing of medical device compliance to global guidance documents and standards
• Conduct microbial ingress and simulated use testing for new product development and lifecycle management activities
• Conduct chemical compatibility studies and sub-visible particulate testing
• Support ISO 10993-compliant biocompatibility and chemical characterization efforts

Requirements:

• Bachelor's degree in a scientific or engineering discipline (Microbiology, Chemistry, Biomedical Engineering, or related)
• 5-7 years of relevant experience in a technical discipline
• Demonstrated knowledge of Good Manufacturing Practices and Good Laboratory Practices
• Ability to analyze complex problems and present technical information professionally

Preferred Qualifications:

• Master's degree in a scientific or engineering discipline
• Experience supporting FDA and/or other regulatory body submissions
• Practical knowledge of sterilization and biocompatibility of medical devices

Salary: $86,320.00 - $129,480.00 per year

Benefits: Health care, vision, dental, retirement, PTO, sick leave, etc.