Principal Engineer Manufacturing/Technology

Nextern; Osseo (MN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health Plan

Retirement Plan

Paid Time Off

Life Insurance

Disability Insurance

Job summary

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer to join our medical device production team. You will manage multiple complex projects while ensuring compliance with FDA and ISO 13485 standards.

The ideal candidate has 5+ years in medical device manufacturing and a strong track record of improving methods and processes. You will lead process development, design fixtures and tooling, and collaborate across QA, R&D, and Production to deliver high-quality

Qualifications

• Bachelor's degree in manufacturing/related field.
• 5+ years in medical device manufacturing.
• Experience with ISO 13485 and FDA regulations.

Responsibilities

• Lead process development, validation activities: IQ/OQ/PQ, BOM, work instructions.
• Troubleshoot and optimize manufacturing processes for quality and efficiency.
• Write, review, and maintain SOPs and process specifications in compliance with FDA/ISO13485.
• Design and implement fixtures, tooling, and equipment for production.
• Lead root cause analyses and CAPA to drive continuous improvement.
• Collaborate with QA, R&D, and Production for smooth product launches.

Skills

CAD

SolidWorks

AutoCAD

SPC

Lean manufacturing

IQ/OQ/PQ

FDA/ISO13485

Root cause analysis

Education

Bachelor's degree in Manufacturing Engineering

Tools

SolidWorks

AutoCAD

Job description

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.

• Process Development Lead manufacturing process development and validation activities: engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
• Troubleshoot & Optimize manufacturing processes for medical devices ensuring efficient production while maintaining quality standards.
• 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.

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

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Life Insurance (Basic, Voluntary & AD&D)
• Short-Term & Long-Term Disability

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.