Systems Engineer - Indianola, PA

Systems Engineer – Indianola, PA

PURPOSE

The Systems Engineer supports system-level engineering activities for medical device development programs, with a focus on risk management, human factors / usability engineering support, and design control execution. This role is embedded on one primary development program and may provide limited support to additional programs as needed.

Working under the guidance of a lead engineer, the Systems Engineer collaborates closely with cross-functional teams and external partners to support compliant product development across the design, verification, validation, and usability lifecycle.

This is an on-site, engineering-level position intended for early–mid career professionals with foundational experience in medical device development.

YOUR TASKS AND RESPONSIBILITIES

• Support system-level engineering activities for medical device programs, including requirements support, interface coordination, and design control documentation;
• Contribute to medical device risk management activities, including development and maintenance of risk documentation and participation in risk reviews;
• Support Human Factors / Usability Engineering activities, including usability documentation and coordination with internal and external Human Factors resources;
• Support verification and validation activities, including usability-related validation, simulated use activities, and collaboration with Verification & Validation/Test engineering and clinical teams as appropriate;
• Participate in change impact assessments and support updates to requirements, risk, verification, validation, and usability artifacts as directed;
• Work cross-functionally with engineering, quality, regulatory, clinical, and external partners to support regulated product development.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Bachelor’s degree in a science-based or engineering-related discipline;
• 2–4 years of professional medical device engineering experience;
• Experience working within FDA design control requirements (21 CFR 820);
• Experience working within a medical device Quality Management System (e.g., ISO 13485);
• Experience supporting Human Factors / Usability Engineering activities in alignment with IEC 62366-1;
• Experience using requirements management tools (e.g., Jama, DOORS, Polarion);
• Ability to work effectively in a cross-functional, regulated development environment;
• Strong written and verbal communication skills.

PREFERRED QUALIFICATIONS

• Master’s degree in Engineering.

Employees can expect to be paid a salary between $62,208.00 to $93,312.00. Additional compensation may include a bonus or incentive compensation (if relevant). 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.

This posting will be available for application until at least 2-2-26.