Manufacturing Engineer - Medical Device

Socket.dev; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Plan

Retirement Plan

Paid Time Off

Wellness Resources

Life Insurance

Family Leave

Disability Insurance

Taco Thursdays

Job summary

Socket.dev is seeking an experienced Manufacturing Engineer with a strong background in medical device production. This role focuses on leading process development and validation, refining methods and equipment to deliver high-quality devices while complying with strict medical device standards.

The ideal candidate has 5+ years in medical device manufacturing and a track record of improving methods, systems and processes.

Qualifications

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.
• Minimum 5+ years of experience in medical device manufacturing engineering; proven experience with medical devices.
• Proficiency in CAD software (SolidWorks, AutoCAD, or similar); knowledge of SPC and lean manufacturing; understanding of IQ/OQ/PQ validation.
• Thorough understanding of ISO 13485:2016 Medical Device Quality Management System.

Responsibilities

• Lead manufacturing process development and validation activities: IQ, OQ, PQ reports, BOMs, and manufacturing instructions.
• Troubleshoot and optimize manufacturing processes to ensure quality and efficiency.
• Write, review, and maintain SOPs, work instructions, and process specifications per FDA and ISO 13485.
• Design, develop, and implement fixtures, tooling, and equipment for medical device production.
• Lead root cause analysis, CAPA, and continuous improvement initiatives to enhance quality and reduce waste.
• Collaborate with QA, R&D, and Production for seamless product launches.
• Other duties as assigned.

Skills

Cross-functional collaboration

Problem solving

Process optimization

Attention to detail

Education

Bachelor's degree in Manufacturing/Mechanical/Biomedical Engineering

Tools

CAD (SolidWorks/AutoCAD)

SPC

IQ/OQ/PQ validation

ISO 13485 knowledge

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.