Manufacturing Engineer - Medical Device

Nextern; Maple Grove (MN); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Plan (Medical, Dental & Vision)

Retirement Plan with Company Match

Paid Time Off, Personal Days, Birthday

Job summary

Nextern in Maple Grove, MN is seeking an experienced Manufacturing Engineer to lead development, validation, and optimization of medical device production processes.

The ideal candidate has 5+ years in medical device manufacturing, strong CAD skills (SolidWorks/AutoCAD), knowledge of SPC and lean methods, and ISO 13485 compliance, collaborating across QA, R&D and production.

Qualifications

• Minimum 5+ years in medical device manufacturing engineering.
• Experience with medical devices, metal components, assemblies preferred.
• Familiarity with FDA/ISO 13485 compliant environments.

Responsibilities

• Lead process development and validation activities (IQ/OQ/PQ) and BOMs.
• Troubleshoot and optimize manufacturing processes for quality and efficiency.
• Write and maintain SOPs and process specifications.
• Design fixtures, tooling, and equipment for production.
• Lead CAPA investigations and drive continuous improvement.
• Collaborate with QA, R&D, and Production for product launches.

Skills

5+ years experience

CAD proficiency

SPC knowledge

Lean manufacturing

ISO 13485 familiarity

Education

Bachelor's degree in Manufacturing/Mechanical/Biomedical Engineering

Tools

SolidWorks

AutoCAD

Job description

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.

DUTIES AND 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.

Other duties and projects assigned.

QUALIFICATIONS:

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

Experience: Minimum 5+ years of experience in medical device manufacturing engineering; proven experience with medical devices (metal based components, assemblies, and processing preferred).

Technical Skills: 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)).

Regulatory Knowledge: Thorough understanding of ISO 13485:2016 Medical Device Quality Management System.

• 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.