Principal Manufacturing Engineer

Nextern; Maple Grove, Northern (MN, KY); Hybrid; USD 130,000 - 165,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan with Company Match

Paid Time Off, Personal Days, Birthday

Life Insurance

Family Leave

Disability Insurance

Birthday Holiday

Job summary

NPX Medical, a division of Nextern, seeks an experienced Manufacturing Engineer in Minnesota to lead process development and validation for medical devices. You will optimize production, draft SOPs, and drive CAPA initiatives while collaborating with QA, R&D and Production for successful launches.

The role requires 10+ years in medical device manufacturing, CAD proficiency (SolidWorks/AutoCAD), and strong knowledge of SPC, lean methods, and IQ/OQ/PQ within ISO 13485 environments.

Qualifications

• Degree in a relevant engineering field is required.
• 10+ years of medical device manufacturing experience.
• Proficiency with CAD software (SolidWorks/AutoCAD).
• Familiarity with SPC and lean manufacturing; IQ/OQ/PQ knowledge.
• ISO 13485:2016 quality management system understanding.
• Experience with metal components and assembly processing.

Responsibilities

• Lead manufacturing process development and validation activities (IQ/OQ/PQ).
• Troubleshoot and optimize manufacturing processes for devices.
• Develop and maintain SOPs, work instructions, and process specs.
• Design fixtures, tooling, and equipment for production.
• Lead CAPA and continuous improvement initiatives.
• Collaborate with QA, R&D, and Production for launches.

Skills

Root cause analysis

Process optimization

Cross-functional collaboration

Quality systems understanding

Education

Bachelor's degree in Manufacturing/Mechanical/Biomedical Eng

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.

Required:

• 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

• 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!!!

Nexternis 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.