Full-Time
Manufacturing Engineer
Medical Devices
Nextern
Contract medical device development and manufacturing
No salary listed
Maple Grove, MN, USA
In Person
Bachelor's
 Manufacturing & Process Engineering (1) |
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- A bachelor's degree in manufacturing engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field is required.
- At least 3 years of experience in medical device manufacturing engineering is required.
- Proven experience with electro-mechanical device assembly and testing is required.
- Experience with single-use disposable medical devices such as catheters, guidewires, or similar products is required.
- Demonstrated experience with the Epicor enterprise resource planning system or similar enterprise resource planning software is required.
- Experience working in FDA-regulated manufacturing environments is required.
- Proficiency in computer-aided design software such as SolidWorks, AutoCAD, or similar software is required.
- Knowledge of statistical process control and lean manufacturing principles is required.
- Understanding of medical device design controls and validation processes is required.
- Experience with process validation, including Installation Qualification, Operational Qualification, and Performance Qualification, is required.
- A thorough understanding of FDA 21 CFR Part 820 Quality System Regulation is required.
- Knowledge of ISO 13485 Medical Device Quality Management System is required.
- Familiarity with ISO 14971 Risk Management for Medical Devices is required.
- Understanding of ISO 10993 biocompatibility requirements for medical devices is required.
- Design, develop, and optimize manufacturing processes for medical devices, including electro-mechanical assemblies and single-use disposable products such as catheters, while maintaining quality standards.
- Write, review, and maintain manufacturing procedures, work instructions, Standard Operating Procedures, and process specifications in compliance with FDA regulations and ISO 13485 standards.
- Design, develop, and implement manufacturing fixtures, tooling, and equipment for medical device production in compliance with design controls.
- Lead root cause analysis investigations, implement corrective and preventive actions, and drive continuous improvement initiatives to improve product quality, reduce waste, and increase manufacturing efficiency.
- Use the Epicor enterprise resource planning system to manage bills of materials, routing operations, work orders, inventory management, and production planning activities.
- Collaborate with Quality Assurance, Regulatory Affairs, research and development, and Production teams to support product launches and manufacturing transfers.
- Ensure manufacturing processes comply with FDA 21 CFR Part 820, ISO 13485, and other applicable medical device regulations.
- Provide technical support to the production floor, troubleshoot manufacturing issues, and implement solutions that maintain production schedules and quality targets.
- Participate in design control activities, including Design History Files, risk analysis, and validation and verification protocols.
- Train production personnel on new procedures and processes and mentor junior engineering staff.
Nextern provides contract engineering and manufacturing services for medical devices across the product lifecycle, collaborating with OEMs, clinicians, and innovators from concept through commercialization. It offers four integrated pillars—Medical Device Product Development, Medical Device Manufacturing, NPX Precision Technologies, and Nextern Consulting Services—covering electromechanical systems, catheters, guidewires, pulse generators, and nitinol components with NPX laser cutting and welding. The company differentiates itself with an end-to-end, globally distributed model and a revenue structure tied to manufacturing output, aligning success with its partners’ commercial performance. Its goal is to enable medical device commercialization by delivering scalable, globally distributed manufacturing and lifecycle support across markets like peripheral vascular, interventional cardiology, structural heart, neuromodulation, and electrophysiology.
Company Size
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Company Stage
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Total Funding
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Headquarters
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Founded
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Simplify's Take
What believers are saying
- June 22, 2026 consulting launch opens higher-margin regulatory and quality services.
- Corey Kranz joined in 2026 as COO, strengthening global operations and supply chain execution.
- Nextern's 2026 site map shows manufacturing capacity in Costa Rica, Vietnam, and China.
What critics are saying
- Employee reviews flag weak management, poor communication, and headcount cuts in 2025.
- Nextern depends on OEM program wins; any customer loss quickly hits manufacturing revenue.
- China, Vietnam, and Costa Rica operations expose Nextern to tariff, logistics, and regulatory shocks.
What makes Nextern unique
- Nextern spans development, manufacturing, consulting, and precision components across five global sites.
- John Hastings became CEO on September 29, 2025, adding seasoned medtech operating leadership.
- Its Maple Grove headquarters centralizes product development, bio-simulation, and commercialization support.
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Benefits
Health Insurance
Dental Insurance
Health Savings Account/Flexible Spending Account
401(k) Retirement Plan
401(k) Company Match
Paid Holidays
Paid Vacation
Gym Membership
Disability Insurance
Life Insurance
Training Programs
Company Social Events