Principal Manufacturing Engineer
Nextern
Summary
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.
Job description
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 (IQ, OQ, PQ)
- Thorough understanding of ISO 13485:2016 Medical Device Quality Management System
- Preferred: Metal based components, assemblies, and processing
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, Birthday Holiday
- Lifetime Membership Subsidy
- Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- Family Leave (Maternity, Paternity)
- Short-Term & Long-Term Disability
- Taco Thursdays
Company overview
Nextern is a collaborative medical device company that specializes in end-to-end medical device product design, development, and manufacturing. Headquartered in Maple Grove, Minnesota, the company operates as a strategic partner for innovators, clinicians, and device companies seeking to accelerate their commercial success. Nextern brings an unmatched core competence in medical device engineering, with expertise spanning from initial concept through full-scale production. The company's capabilities include catheter design, structural heart technologies, neurostimulation systems, wireless connected devices, and surgical robotics. With ISO 13485 certification and FDA registration, Nextern maintains global manufacturing facilities across the United States, Costa Rica, Vietnam, and China, providing flexible production solutions tailored to specific client requirements. The company's unique business model treats clients as collaborators rather than customers, investing in design and development services to build long-term manufacturing partnerships. Nextern's technical expertise covers advanced materials including Nitinol, stainless steel, platinum iridium, and other biocompatible alloys, with specialized capabilities in laser cutting, welding, braiding, and post-processing for complex medical device applications.