Senior Engineering Tech – Medical Devices Design & Change

Aspen Surgical; Caledonia (MI); On-site; USD 60,000 - 90,000; Full time

Job summary

Aspen Surgical is seeking a Senior Engineering Technician to provide technical support to the design engineering team, manage change orders, and perform design-related testing and remediation on medical devices to support product continuity and growth.

The role requires knowledge of FDA/ISO regulations, cross-functional collaboration, and strong project management, with duties including updating DHFs and Device Master Records, and responding to design-related inquiries.

Qualifications

• High School Diploma or GED.
• 2 year technical degree preferred.
• 3-5 years of experience in medical design supporting registrations and DHFs.
• Continuous learning through professional associations.
• Regulated industry experience: FDA, ISO 13485, ISO 14971, MDSAP, EU MDR.
• Strong project management and issue resolution skills.
• Ability to manage multiple projects simultaneously.
• Proficient verbal, written and interpersonal communication.
• Proficient in Microsoft Office (Word, Excel, Outlook).

Responsibilities

• Support design changes and DHF elements for core and acquired products.
• Create and update design history file elements and DHFs.
• Manage change orders and projects for product changes and discontinuations.
• Serve as design engineering resource in cross-functional projects.
• Develop project plans with tasks, timelines, and milestones.
• Drive deadlines with cross-functional teams per project plan.
• Ensure products meet customer specs, safety, and regulatory requirements.
• Resolve design issues with vendors and internal teams.
• Update Device Master Records and respond to inquiries.

Skills

Project management

Communication skills

MS Office

Regulatory knowledge

Team collaboration

Education

High School Diploma/GED

Technical degree preferred

Job description

Aspen Surgical is seeking a Senior Engineering Technician to provide technical support to the design engineering team, manage change orders, and perform design-related testing and remediation on medical devices to support product continuity and growth.

The role requires knowledge of FDA/ISO regulations, cross-functional collaboration, and strong project management, with duties including updating DHFs and Device Master Records, and responding to design-related inquiries.