Bayer Staff Engineer Quality (Part Time 20 hours) in St. Louis, Missouri
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Staff Engineer Quality (Part Time 20 hours)
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Staff Engineer Quality (Part Time 20 hours), are to:
Participate as Quality Element Team member for design and development planning documents and design change requests pertaining to Software as a Medical Device (SaMD) and Artificial Intelligence (AI) product;
Review product requirements, system requirements, software requirements specifications, software architecture specifications, software detailed designs requirements and utilize these to assess complaints against SaMD and AI products;
Review Risk Management documentation for SaMD and AI Products and complete Risk Assessment for complaints against these Medical Devices;
Act as a process advisor to coordinate risk controls, specification traces, verification / validation testing and anomalies tracking for resolution;
Work closely with the software development and risk management and Corrective Action/Preventive Action (CAPA) teams as needed;
Help guide Research and Development and Service teams through Quality Management System to ensure software is performing in compliance to internal procedures, as well as the requirements of FDA, ISO, and other regulatory bodies.
This role will we Part Time, 20 hours per week.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Bachelor’s degree in Computer Science, Computer Engineering, Software Engineering or Biomedical Engineering;
At least three years in the field of software with preferably hands on experience in a technical Quality role supporting a product design function in the development, testing, validation or release of Software in medical devices industry;
Thorough understanding of software quality assurance principles, practices and metrics, as well as best practices that foster high quality software;
Excellent analytical, problem solving, organizational and communication skills;
Demonstrated work experience in a role within a Design Quality function with responsibility of Quality Assurance and Compliance for device software in FDA regulated products;
Proven record supporting the development and execution of software test protocols for complex medical devices;
Familiarity with EN 62304, EN ISO 14971, EN 62366, FDA regulations and international standards applicable to medical device design, development, verification and validation;
Working knowledge of FDA guidance for Medical Device Software Validation.
Experience as a software developer / test engineer;
Knowledge of AI with Medical Devices.
Entirely remote jobs that could be performed in Colorado: Employees can expect to be paid a salary of approximately between $47,900 to $71,750. Additional compensation may include a bonus. Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Location: United States : Pennsylvania : Indianola || United States : Residence Based : Residence Based
Reference Code: 341201