Sr Engineering Tech (Design)

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

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