Senior Medical Device Design Technician

Aspen Surgical; Michigan; On-site; USD 70,000 - 90,000; Full time

Job summary

Aspen Surgical, located in the United States (Michigan), is seeking a Senior Engineering Technician to support the design engineering team. You will manage change orders, maintain design history files, and coordinate testing/remediation activities for medical devices to sustain growth and regulatory compliance.

The role requires 3–5 years in medical design with domestic and international registrations, strong project management, and solid communication skills.

Qualifications

• High School Diploma or GED is required.
• 2-year technical degree preferred.
• 3-5 years of medical design experience with domestic and international registrations and DHF.
• Regulated industry experience: FDA, ISO 13485, ISO 14971, MDSAP, EU MDR.
• Strong project management skills and ability to troubleshoot and resolve issues.
• Proficient verbal, written and interpersonal communication.
• Positive teamwork and attitude to support design development.

Responsibilities

• Create and update DHF elements for core, acquired, and migrated products.
• Manage projects for product changes and discontinuations.
• Support cross-functional projects as the design engineering resource.
• Develop project plans with tasks, timelines, milestones and execute to meet deadlines.
• Drive deadlines with cross-functional team members per project plan.
• Ensure products meet customer specs and regulatory safety within timeframes.
• Resolve design issues with vendors, manufacturing, and internal groups.
• Participate in ideation sessions with the design engineering team.
• Maintain regulatory knowledge by reviewing FDA, ISO, MDD/MDR updates.
• Assist with design-related customer inquiries.
• Update Device Master Records.

Skills

Project management

Interpersonal communication

Teamwork

Troubleshooting

Education

High School Diploma or GED

2-year technical degree preferred

Tools

Microsoft Office (Word, Excel, Outlook)

Job description

Aspen Surgical, located in the United States (Michigan), is seeking a Senior Engineering Technician to support the design engineering team. You will manage change orders, maintain design history files, and coordinate testing/remediation activities for medical devices to sustain growth and regulatory compliance.

The role requires 3–5 years in medical design with domestic and international registrations, strong project management, and solid communication skills.