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Manufacturing – Quality Assurance (QA) Engineer for Innovative Medical Device Company

OnLume Inc.

This is a Contract position in Las Vegas, NV posted August 1, 2022.

OnLume Surgical is creating the future of medical imaging devices for image-guided surgery.

We are seekinga highly motivated, creative, and experienced manufacturing engineer to join our team.This position is responsible for manufacturing engineering activities at OnLume Surgical.Responsibilities and Duties Include:Work with contract manufacturers to plan workflows, design/employ effective protocols in process testing, establish equipment maintenance and calibration schedules, and manage analogous manufacturing activities.
• Establish and monitor supplier capability.

Identify and implement corrective actions to eliminate supplier performance shortcomings.
• Evaluate OnLume Surgical designs for manufacturability.

Identify design improvements that reduce costs, increase quality, and enhance serviceability.
• Implement and manage service stock and repair/return center.
• Manage and monitor the supply chain including the transfer of design outputs.
• Oversee continuous improvement projects.
• Identify and correct quality assurance process bottlenecks and suggest actions for improvement
• Identify key performance indicators (KPIs) for product quality.
• Collect quality assurance data and both prepare and present reports and metrics to Senior Management.
• Function as a manufacturing engineering subject matter expert on OnLume Surgical product development teams.
• Contact for factory audits.
• Adhere to OnLume Surgical policies and procedures.
• As a Manufacturing/QA Engineer, you will partner and report to the VP of Regulatory and Quality Assurance with interaction with the VP of Engineering and Quality Systems Manager.Competency Requirements Include:5 years of experience as a manufacturing engineer in a medical electrical equipment or optical instrumentation industry.
• Demonstrated proficiency in managing manufacturing engineering aspects of an organization’s supply chain.
• Experience developing manufacturing processes that comply with applicable regulations and corporate policies and practices.
• Demonstrated success at clear communications, problem-solving, and interpersonal skills with both internal and external stakeholders.
• Excellent communication skills, both oral and written
• Ability to prioritize workloads and work independently while maintaining team focus.
• Ability to travel (<10% of the time).
• Excitement to tackle challenges and passion to thrive.Educational requirements:Bachelor’s degree in mechanical, industrial, or electrical engineering.

Advanced degree is a plus.Other Employment Details:Benefits:medical, dental, vision, life, short-term disability insurance, PTO, and holiday payJob Type: Full-timeLocation: OnLume home office in Madison Wisconsin.

Travel as necessary to fulfill responsibilities andduties.COVID-19 considerations: Remote work is temporarily optional due to COVID-19.Questions?

Please contact: