Sr Engineering Tech (Design)

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

About Aspen

We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people’s lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.

We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people’s lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.

Summary

The Senior Engineering Technician is responsible for providing technical support to the design engineering team, managing change orders and completing design related testing/remediation activities on medical devices to support the growth, cost profile, and business continuity of Aspen Surgical products while working in a collaborative team environment.

In This Position, You Will Have The Opportunity To

Support Medical Device Changes and Design History Files

• Create and update design history file elements for core products, acquired products, and other business migrations.
• Manage projects for product changes and discontinuations.
• Support cross functional projects as the design engineering resource.
• Develop project plans including tasks, deliverables, timelines, milestones and execute the project to meet deadlines with the support and engagement of cross functional groups.
• Use influencing skills to drive project deadlines with cross functional team members as outlined in the project plan.
• Work with various internal teams to ensure that products are produced meeting customer specifications and are safe and effective while keeping within established time frames.
• Resolve design issues of existing products with vendors, manufacturing, and various internal groups.
• Participate in ideation sessions with the design engineering team.
• Maintain current regulatory knowledge base by reviewing new regulations from domestic and international governing bodies-FDA, BSI
• Assist with design related customer inquiries
• Update Device Master Records

What You Need To Succeed In This Position

• High School Diploma or General Education Degree (GED)
• 2 year technical degree preferred
• 3-5 years of experience in medical design supporting domestic and international registrations and design history files.
• Continuous learning focus to advance job knowledge through professional associations etc.
• Regulated industry experience that includes, but not limited to, FDA, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements.
• Strong project management skills and ability to troubleshoot and resolve project issues.
• Ability to complete multiple projects simultaneously.
• Proficient verbal, written and interpersonal communication skills
• Positive teamwork and attitude required to support the design and development environment
• Proficient in Microsoft Office including word, excel and outlook

We’re proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.