Senior Principal Engineer

About the role

Lead medical device software product design & development for radiology product portfolio; gather & develop requirements; assess regulatory design controls & industry standards; translate requirements into application features; support software testing, design review, & verification and validation activities; contribute to regulatory documentation & submissions; provide input for technical design & architecture decisions; work as part of team to coordinate priorities & deadlines; mentor junior team members.

Responsibilities

• Gather and develop requirements for medical device software products
• Assess regulatory design controls and industry standards
• Translate requirements into application features
• Support software testing, design review, and verification/validation activities
• Contribute to regulatory documentation and submissions
• Provide input for technical design and architecture decisions
• Work as part of a team to coordinate priorities and deadlines
• Mentor junior team members

Requirements

• Master’s in Computer, Electrical, Electronics, or Mechanical Engineering or closely-related technical field & 4 years experience in senior-level medical device product development position(s)
• Designing and developing embedded application software for radiology injection systems across the complete software development lifecycle
• Architecting software systems and/or sub-systems, including imaging system interfaces
• Applying medical device standards for Class-2 medical device development, including ISO 11898-1 & CiA 301, 425-1 and 425-2
• Programming in C & C++ for Linux and Windows cross-platforms and/or real-time operating systems
• Writing code in JSON, gRPC, TLS, TPM, Qt, Shell, & Python to develop product security features and test tools, including injector & scanner simulations
• Implementing complex integrations with DICOM, HL7, & MIRTH Connect
• Using GitHub, Windchill, RQM, DNG & Jira to manage source code, test cases, requirements & related Design History File documentation

Qualifications

• Bachelor’s in said fields & 6 years progressive, post-Bachelor’s stated experience

Skills

• C/C++ programming
• Software development for medical devices
• Medical device standards (ISO 11898-1, CiA 301, 425-1, 425-2)
• Embedded systems development
• Software testing and validation
• Medical device regulatory compliance
• Collaboration and mentoring

Benefits

• Health care
• Vision
• Dental
• Retailment
• PTO
• Sick leave

Pay

Employees can expect to be paid a salary between $162,000.00 to $185,000.00. Additional compensation may include a bonus or commission (if relevant).

Schedule

Position may telecommute from home office location within reasonable commuting distance of Indianola, PA up to 1 day per week.

Additional Information

Up to 5% international travel required.

Contact Us

To apply, mail your resume to:

Cascinda Fischbeck, Bayer HealthCare LLC
800 N. Lindbergh Blvd, E2NE
St. Louis, MO 63167

Email your resume to: BHC_careers@bayer.com

Include reference code 871798 with your resume.

Equal Opportunity Employer Statement

Bayer Healthcare LLC is an Equal Opportunity Employer/Disabled/Veterans.

Bayer Healthcare LLC 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.