Principal Manufacturing Engineer

Job Title:

Principal Manufacturing Engineer

Job Summary:

We are seeking a Principal Manufacturing Engineer to partner closely with R&D in developing complex robotic capital equipment. This role is responsible for translating design intent into manufacturable, testable, and scalable systems from early concept through First-in-Human and beyond. It includes defining and building the manufacturing system and production approach from the ground up, with a clear focus on cost of goods and scalability.

This role combines hands-on build support with system-level manufacturing leadership. The individual will work side-by-side with engineering during key builds and debugging efforts, while also establishing scalable manufacturing processes, optimizing cost of goods, and influencing design decisions in real time.

What You’ll Do:

• Embed with R&D to influence design for manufacturability, assembly, test, and serviceability (DfX) from early development
• Define and build the manufacturing system and production approach from the ground up, including line design, process flow, and material flow
• Drive design and process decisions to meet the target cost of goods (COGS) while maintaining performance and quality requirements
• Lead hands-on support of engineering builds, including assembly, troubleshooting, and process iteration
• Define and develop build processes, work instructions, and core manufacturing documentation (DMR elements)
• Establish manufacturing test strategy, including integration of test methods into builds
• Identify and mitigate manufacturing and supply chain risks, including long-lead components and supplier readiness
• Drive system-level problem solving across mechanical, electrical, and software interfaces
• Partner with Quality to ensure appropriate application of design controls without slowing development velocity
• Support development of the long-term manufacturing strategy

Skills and Abilities:

• Technical Skills: Strong understanding of medical device manufacturing processes, DfX principles, and system integration for complex electromechanical products.
• Analytical Skills: Ability to analyze and solve complex system-level problems across mechanical, electrical, and software domains
• Communication Skills: Strong verbal and written communication skills to influence cross-functional teams and document processes clearly
• Teamwork: Ability to work collaboratively with R&D, Quality, and Supply Chain in a fast-paced environment
• Adaptability: Comfortable operating in an evolving environment with shifting priorities and high ambiguity

What you Bring:

Required:

• Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Electrical Engineering, or related field
• Experience: 10 years of manufacturing engineering experience, including work in medical devices and complex electromechanical systems (robotics, capital equipment, or similar)
• Experience influencing design and manufacturing decisions to achieve cost targets (COGS) and scalability
• Experience using statistical or data analysis tools (e.g., Minitab, JMP or similar) for process analysis, capability, and problem solving
• Hands-on experience supporting early-stage builds and system integration
• Strong understanding of DfX principles (DFM, DFA, DFT, serviceability)
• Experience working within design controls (DMR, DHR, traceability) in a regulated environment
• Demonstrated ability to troubleshoot and resolve system-level issues across mechanical, electrical, and software domains
• Experience developing build processes, work instructions, and early manufacturing/test methods
• Proficiency with CAD tools (e.g., SolidWorks) to support DfM, layouts, or fixture design
• Demonstrated ability to operate effectively in cross-functional, fast-paced development environments

Preferred:

• Advanced degree in Engineering or related field
• Experience supporting products from concept through FIH and early production
• Background in robotics, motion systems, or complex capital equipment
• Experience with test method development and validation (TMD/TMV)
• Familiarity with supplier development and early-stage sourcing in regulated environments
• Six Sigma or similar process improvement certification

Work Environment:

• Travel requirement: ~10–20% to support suppliers, builds, and development activities
• This position operates in a professional office and lab environment
• The work setting is fast-paced and energetic
• Employees typically work at a desk or workstation using standard office equipment such as computers, phones, printers, and collaboration tools
• The role also includes time in lab or build environments supporting hands-on system assembly, integration, and troubleshooting
• The role may involve extended periods of sitting, regular use of a computer, and occasional meetings, both in person and virtual, with flexibility required to support key milestones and deadlines