Primary Manufacturing & Process Engineer

Virtual Incision; Lincoln (NE); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k)

Flexible working hours

PTO

Job summary

Virtual Incision is seeking a Manufacturing & Process Engineer to join our team designing, prototyping, testing, and producing miniature robotic surgical systems.

You will develop, validate, and continuously improve manufacturing processes, supporting production, NPI, design transfers, and scale-up in a fast-paced, regulated setting.

Qualifications

• BS in Engineering or related technical discipline.
• 1–4 years in manufacturing/process engineering or related field.
• Strong problem-solving and analytical skills.
• Experience with statistical analysis and process improvement methods.
• Ability to read and interpret engineering drawings and manufacturing specs.
• Strong communication and collaboration skills.
• Ability to work independently in cross-functional teams.

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 changes.
• Develop and implement production process controls, risk analyses, and validation activities.
• Perform qualification activities and maintain IQ/OQ/PQ docs.
• Analyze and improve processes using DMAIC, Gage R&R, Cp, Cpk, and SPC.
• Identify and implement improvements to quality, yield, throughput, and cycle time.
• Troubleshoot issues and drive root-cause investigations with corrective actions.
• Maintain and improve process documentation and work instructions.
• Collaborate with Engineering, Quality, Supply Chain, and Operations.
• Work with suppliers on equipment procurement and tooling development.
• Support development of manufacturing test systems for complex assemblies.
• Participate in process FMEA and risk assessments.
• Ensure compliance with QMS and regulatory standards.

Skills

Problem solving

Analytical skills

Statistical analysis

Reading engineering drawings

Education

BS in Engineering

Tools

SolidWorks

Job description

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.

Status: Exempt

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