Senior Medical Device Engineering Technician

Aspen Surgical; Caledonia (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Aspen Surgical is seeking a Senior Engineering Technician to support the design engineering team, manage change orders, and perform design testing/remediation for medical devices. The role focuses on regulatory compliance, documentation, and cross-functional collaboration to sustain product growth and quality.

The position emphasizes maintaining current regulatory knowledge (FDA, ISO standards) and ensuring safe, effective products delivered on schedule.

Qualifications

• 3-5 years of experience in medical design supporting domestic and international registrations and design history files.
• Strong project management skills and ability to troubleshoot and resolve project issues.
• Proficient in Microsoft Office including Word, Excel and Outlook.

Responsibilities

• Support design history files and change management for core and acquired products.
• Manage projects for product changes and discontinuations and ensure timelines.
• Collaborate with cross functional teams to meet customer specifications and regulatory requirements.

Skills

Project management

Regulatory knowledge

Cross-functional collaboration

Documentation

Verbal and written communication

Education

2-year technical degree

Tools

Microsoft Office

Job description

Aspen Surgical is seeking a Senior Engineering Technician to support the design engineering team, manage change orders, and perform design testing/remediation for medical devices. The role focuses on regulatory compliance, documentation, and cross-functional collaboration to sustain product growth and quality.

The position emphasizes maintaining current regulatory knowledge (FDA, ISO standards) and ensuring safe, effective products delivered on schedule.