Senior Medical Device Design Technician

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