Sr. Engineering Tech (Design)

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

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.