Principal Manufacturing Engineer

Nextern; Osseo (MN); On-site; USD 130,000 - 165,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Vision)

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND Bday

Lifetime Membership Subsidy and Welll

Life Insurance (Basic, Voluntary &

Family Leave (Maternity, Paternity)

Disability (Short-Term & Long-Term)

Taco Thursdays!!!

Job summary

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer to lead process development and validation for medical devices in a regulatory-driven environment. You will collaborate with QA, R&D, and production to ensure compliant, high-quality production processes.

The role requires 10+ years in medical device manufacturing, proficiency in CAD tools, and knowledge of SPC and lean manufacturing. Salary ranges reflect senior expertise and location in Minnesota.

Qualifications

• 5+ years of experience in medical device manufacturing engineering.
• Experience with ISO 13485 and FDA regulations is preferred.
• Knowledge of SPC and lean manufacturing.

Responsibilities

• Lead manufacturing process development and validation activities (IQ/OQ/PQ).
• Troubleshoot and optimize manufacturing processes for medical devices.
• Write and maintain SOPs, work instructions, and process specs.

Skills

Process development

Troubleshooting

Documentation

Fixture design

CAPA & CI

Cross-functional collaboration

Education

Bachelor’s degree in Manufacturing, Mechanical, Biomedical Engineering

Tools

SolidWorks

AutoCAD

Job description

NPX Medical is a division of Nextern – a global, vertically integrated medical device development and manufacturing platform. We specialize in precision metal components and assemblies, with deep expertise in nitinol engineered components, precision laser cutting and processing, and advanced catheter technologies. Our engineers bring decades of combined experience – from R&D and rapid prototyping through full commercial production.

We are seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic manufacturing team. This role requires a versatile professional who can manage multiple complex projects while ensuring compliance with stringent medical device industry standards and regulations. The ideal candidate will have 5+ years of experience in medical device manufacturing, demonstrating improved: manufacturing methods, systems and processes to produce a high-quality product.

Responsibilities

• Process Development Lead manufacturing process development and validation activities: engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
• Process Support & Optimization: Troubleshoot & Optimize manufacturing processes for medical devices ensuring efficient production while maintaining quality standards.
• Technical Documentation: Write, review, and maintain manufacturing procedures, work instructions, Standard Operating Procedures (SOPs), and process specifications in compliance with FDA regulations and ISO 13485 standards.
• Fixture & Tooling Design: Design, develop, and implement manufacturing fixtures, tooling, and equipment for production of medical devices, ensuring proper functionality and compliance with design controls.
• Problem Solving & Continuous Improvement: Lead root cause analysis investigations, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives to enhance product quality, reduce waste, and improve manufacturing efficiency.
• Cross-Functional Collaboration: Work closely with Quality Assurance, R&D, and Production teams to ensure seamless product launches.

Requirements

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.
• 10+ years of experience in medical device manufacturing engineering
• Proficiency in CAD software (SolidWorks, AutoCAD, or similar)
• Knowledge of statistical process control (SPC) and lean manufacturing; understanding of medical device validation processes (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)).
• Thorough understanding of ISO 13485:2016 Medical Device Quality Management System.
• Metal based components, assemblies, and processing

Salary range: $130,000 to 165,000 depending on skills and experience

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.