Primary Manufacturing & Process Engineer

Virtual Incision is advancing robotic-assisted surgery with a focus on expanding access to minimally invasive care. We are a growing medical technology company where experienced leaders have the opportunity to make a meaningful and visible impact.

Why Virtual Incision:

• Work on innovative robotic surgical technology with the potential to improve patient care.
• Join an experienced, collaborative team focused on clinical excellence and disciplined execution.
• Take meaningful ownership of products and programs in a hands-on environment.
• Work in a culture that values technical rigor, practical problem-solving, and teamwork.
• Competitive benefits including medical, dental, vision, disability, and life insurance, 401(k), flexible working hours, and PTO.

Job Summary:

As a Manufacturing & Process Engineer at Virtual Incision, you will be part of a team that designs, prototypes, tests, and produces innovative miniature surgical robots and related equipment that advance the field of surgery. This role is responsible for developing, validating, implementing, and continuously improving manufacturing processes that support the production of Virtual Incision's robotic surgical systems.

The Manufacturing & Process Engineer partners closely with Engineering, Quality, Supply Chain, and Operations to support production, new product introductions, design transfers, process improvements, and manufacturing scale-up activities. The successful candidate will be a hands-on problem solver who thrives in a fast-paced, highly regulated environment and is passionate about improving product quality, manufacturing efficiency, and operational performance.

Responsibilities:

• Develop and implement manufacturing processes, tools, fixtures, equipment, and facility infrastructure to support production operations.
• Support design transfer activities and ensure manufacturing readiness for new products and product changes.
• Develop and implement production process controls, including risk analysis activities, facility monitoring, process validations, and test method validations.
• Perform qualification activities and maintain associated documentation, including IQ/OQ/PQ protocols and reports where required.
• Analyze and improve manufacturing processes, components, and products using statistical and continuous improvement methodologies such as DMAIC, Gage R&R, Cp, Cpk, and SPC.
• Identify and implement process improvements that improve product quality, manufacturing yield, throughput, cycle time, and operational efficiency.
• Troubleshoot manufacturing issues and drive root cause investigations to implement effective corrective actions.
• Develop, maintain, and improve manufacturing process documentation, including assembly procedures, inspection procedures, work instructions, and product specifications.
• Collaborate with Engineering, Quality, Supply Chain, and Operations teams to ensure successful implementation of manufacturing and process improvements.
• Work with suppliers and vendors to support equipment procurement, tooling development, process improvements, and ongoing manufacturing support.
• Support the development and implementation of manufacturing test systems for complex electromechanical products.
• Participate in manufacturing risk assessments, including process FMEA activities.
• Ensure compliance with company policies, Quality Management System requirements, and applicable regulatory standards.
• Support internal and external audits as needed.
• Participate in continuous improvement initiatives that enhance manufacturing performance, product quality, and operational scalability.
• Perform other duties as assigned.

Qualifications:

Required

• Bachelor of Science degree in Engineering or a related technical discipline.
• 1-4 years of manufacturing engineering, process engineering, production support, or related engineering experience.
• Strong problem-solving and analytical skills.
• Experience with statistical analysis and process improvement methodologies.
• Ability to read and interpret engineering drawings, technical documentation, and manufacturing specifications.
• Strong communication and collaboration skills.
• Ability to work independently and effectively within cross-functional teams.

Preferred

• Mechanical design and CAD software experience, with SolidWorks experience preferred.
• Experience building and implementing manufacturing test systems for complex electromechanical assemblies.
• Experience within the medical device industry or another regulated manufacturing environment.
• Knowledge of FDA Quality System Regulations and ISO 13485.
• Experience facilitating manufacturing risk assessments using pFMEA methodologies.
• Experience sourcing, qualifying, and implementing manufacturing equipment.
• Experience collaborating with suppliers and contract manufacturers.
• Experience supporting robotic, electromechanical, or advanced technology products.
• Lean Manufacturing and/or Six Sigma experience.

Salary: DOE

Status: Exempt

Virtual Incision is an Equal Opportunity Employer and values diversity in its workforce.