were a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

Theres no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary:

In this role, you will be responsible for generating DHF documentation and managing R&D activities, including all stages according to Design Controls (R&D, V&V, etc.). In this role you will be involved in the design of newly developed medical devices as well as supporting existing designs. The position is temporary for 7 months maternity leave replacement.

Essential Duties and Responsibilities:
Create, maintain, and update Design History File content per Design Control. Initiate, perform, and approve R&D technical design reviews. Author, review and approve product development / Verification / Risks / R&D related documentation.
Provide technical knowledge of system engineering and its application to developing cost effective, reliable, and high-quality solutions that address customer and business needs.
Participate in applicable risk management activities, identify potential risks and find solutions to prevent these and/ or solve these.
Work in collaboration with team members and functional groups.
Generate and/or review and/or approve verification and/or validation plans, protocols, and reports, including test method validation, Engineering studies and usability studies as assigned including R&D support in test methods activities.
Define, drive and manage change management and communications activities that support assigned projects.
Shared team responsibilities of DHF, device/system performance, quality, and technical implementation.
Other duties as assigned.