V & V Systems Engineer - Indianola, PA

Bayer•Indiana Township, PA

1d•Onsite

About The Position

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. V & V Systems Engineer - Indianola, PA V&V 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.

Requirements

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

Nice To Haves

Master’s degree in Engineering.

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.