Production Quality Engineer

Blu Omega is seeking a Production Quality Engineer to help scale a production line for advanced biomedical optical device. This role will play a critical part in transitioning from prototype builds to scalable manufacturing, ensuring quality, consistency, and regulatory compliance across all stages of production.

This position sits at the intersection of quality, manufacturing, and engineering leadership, working closely with a team of hands-on engineers to bring a next-generation diagnostic device to market.

Responsibilities

• Assist in establishing and implementing quality control systems aligned with FDA and ISO standards for medical devices
• Help setup and optimization of production processes, from incoming inspection through final product shipment
• Help build and scale a production line to support increased manufacturing volume and consistency
• Partner with engineering teams to improve product design, assembly processes, and cost efficiency
• Identify and resolve production bottlenecks impacting quality, throughput, or reliability
• Help oversee inventory flow, including receiving, inspection, assembly integration, testing, and shipping
• Support documentation practices with a focus on efficient, digital-first quality systems
• Contribute to continuous improvement initiatives across manufacturing and quality operations

Qualifications

• 5+ years of experience in manufacturing, production engineering, or quality engineering
• Experience with FDA-regulated environments and ISO quality systems (medical device preferred)
• Background in optical or laser-based systems
• Strong mechanical engineering foundation with SolidWorks proficiency
• Experience scaling production from prototype or low-volume builds to repeatable manufacturing
• Demonstrated ability to lead teams and work cross-functionally with engineering

Nice to Have

• Experience with electronic testing (multimeters, oscilloscopes, PCB validation)
• Familiarity with automated systems and machine vision
• Programming experience (Python, C/C++) and embedded systems (e.g., Raspberry Pi)
• Experience with rapid prototyping and manufacturing methods (machining, laser cutting, 3D printing)

Salary Range

$115K-$200K

Our final salary offer will be based on several factors, including depth of technical skills, work experience, education, certifications, and clearance

What Blu Omega Can Offer You

• Competitive benefits including Health Insurance, 401K w/ match, Paid Time Off and more.
• Results driven culture that embrace our core values
• Rewarding work contributing to our Nation’s mission critical programs

Blu Omega is a Woman Owned Small Business Federal Technology services firm headquartered in Washington DC and supporting clients nationally. We provide Technology solutions for enterprise and government customers. Our team has a past performance in a diverse range of programs including those for Data Management, Cloud/Infrastructure, Software Development and Enterprise Applications.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.