Sr Engineering Tech (Design)

Talent Acquisition Team•Caledonia, MI

20h

About The Position

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.

Requirements

High School Diploma or General Education Degree (GED)
3-5 years of experience in medical design supporting domestic and international registrations and design history files.
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

Nice To Haves

2 year technical degree preferred
Continuous learning focus to advance job knowledge through professional associations etc.

Responsibilities

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