Sr. Manufacturing Engineer

Working Location: MINNESOTA, BROOKLYN PARK 

Workplace Flexibility: Onsite

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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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 develops, improves, and 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.

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.
• Explore, evaluate, and implement optimal technologies and processing methodologies to improve quality and reliability and to reduce manufacturing cost. Cater technical solutions and process design to the product attributes (e.g. volume, reliability, cost targets).
• 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.

Job Qualifications

Required:

• B.S. degree in Engineering or Physics, or a related field.
• Minimum 5 years of experience with a bachelors, 4+ with a masters, working in a manufacturing engineering or related role.
• Experience working in a regulated medical device environment is a strong plus.
• Experience working in a team setting bringing processes from development through validation. 
• Expertise with the development of processes and related documentation.
• Strong good documentation practices (GDP) are required.
• Working knowledge of some or all core man