Manufacturing Engineer II

at  Olympus Corporation of the Americas

Workplace Flexibility: Onsite
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

JOB DESCRIPTION

The position holder is responsible for the execution and documentation of process development deliverables and activities for Single Use Endoscopes (SUE) product development and launch to production.
The position holder implements the optimal manufacturing processes according to product delivery, operations, and business requirements to launch products effectively, on time, with high reliability and the right cost.
The position holder responsible for proactive engineering responses in alignment with Regulatory compliance requirements.

ABOUT US:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

OUR PURPOSE IS TO MAKE PEOPLE’S LIVES HEALTHIER, SAFER, AND MORE FULFILLING.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View
We deliver on our purpose and our core values by staying True to Life.

JOB DUTIES

• Complete process development activities under the guidance and leadership of senior engineers to meet project goals including process characterization and optimization, prototype development, process validation, pilot build, process control and product release readiness.
• Ensure outstanding product development processes including FDA compliance and alignment to the Phase Gate product development process.
• Execute studies to understand and optimize processes (e.g. design of experiments).
• Responsible for the development and validation of capable production and test processes that meet operational objectives as assigned.
• Authors test protocols and reports and related technical documentation in accordance with good documentation practices to ensure that studies and tests are in executed in an effective and compliant manner.
• Executes process validation and test method validation activities with statistically relevant and robust methods.
• Contribute to process risk analysis and control systems development and implementation.
• Partner with industrial engineering and manufacturing peers to ensure that processes developed are suitably industrialized and able to be effective at commercial scale.
• Works with other functions to standardize, leverage and implement engineering tools and establish best-demonstrated practices.
• Provides Process Engineering support all necessary projects and activities.
• Execute and drive process capabilities, and risk documentation for project assigned.
• All Other Essential Duties as directed.