Manufacturing Engineer – Medical Devices & Process Improvement

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

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.