Sr. Manufacturing Engineer - NPX

Nextern; Maple Grove (MN); On-site; USD 100,000 - 140,000; 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 Boss

Birthday Holiday

Lifetime Membership Subsidy and Wellne

Life Insurance (Basic, Voluntary & AD&

Family Leave (Maternity, Paternity)

Short-Term & Long-Term Disability

Taco Thursdays

Job summary

NPX Medical, a division of Nextern, is seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic team.

You will lead process development and validation, create procedures, and collaborate with QA, R&D, and production to ensure compliant, high-quality manufacturing.

The ideal candidate has 5+ years in medical device manufacturing, CAD proficiency (SolidWorks/AutoCAD), SPC/lean expertise, and ISO 13485 knowledge.

Qualifications

• 5+ 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 (IQ, OQ, PQ).
• Thorough understanding of ISO 13485:2016 Medical Device Quality Management System.
• Experience with metal-based components, assemblies, and processing.

Responsibilities

• Lead process development and validation activities: IQ, OQ, PQ reports, BOM, assembly instructions, and manufacturing procedures.
• Troubleshoot and optimize manufacturing processes for medical devices while maintaining quality.
• Write, review, and maintain SOPs, work instructions, and process specifications in FDA/ISO 13485 compliance.
• Design, develop, and implement fixtures, tooling, and equipment for production with design control compliance.
• Lead root cause analysis, CAPA, and drive continuous improvement to enhance quality and efficiency.
• Collaborate with Quality Assurance, R&D, and Production teams for smooth product launches.

Skills

Statistical process control

Lean manufacturing

ISO 13485 knowledge

IQ/OQ/PQ validation understanding

Education

Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field

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.
• 5+ 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: $100,000 to 140,000 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.