Design Engineer - International

We love what we do! At Aspen Surgical we live our values of Respect, Transparency, Speed, Empowerment, Passion and Fun 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. Do you want to be appreciated for your hard work? Be a member of a dynamic, fast-growing organization? View your job as a joy rather than a burden? Then we have a position for you!

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

Support design development and sustaining functions for international registrations of core, acquired, and other business migrations, including FDA, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements; ensure that product changes meet both internal and external customer requirements, with a strategic focus on international; evaluate proposed changes to existing products, including plastic injection molding, textile, and/or converting part design and implementation, and complete deliverables required to implement the change through individual efforts or cross functional teams; conduct the development and evaluation of designs which meet defined product requirements and that are optimized for production, reliability, and overall cost to the business; recommend and communicate project plans, tasks and deliverables, and manage time to meet project deadlines; participate in troubleshooting and problem solving efforts related to development projects; provide thorough engineering analysis and data; work with manufacturing throughout the development phases of medical single/reusable disposable products, in order to ensure that products are produced in a safe, efficacious and quality manner to  meet international registration requirements, while keeping within established time frames; interface with vendors, manufacturing facilities and various internal groups to resolve design and manufacturing issues of new and existing products; support design related activities as they relate to Cleanroom Standards ISO 14644-1; remain current with technology and trends within the business; provide general technical assistance to various inter departments/individuals as necessary in the exploration of new opportunities and/or problem solving issues with existing products. 

EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:

• Bachelor’s Degree in Design Engineering, Mechanical Engineering or closely related engineering field and 4 years’ engineering experience in medical related design 
• 4 years of regulated industry experience that includes, but not limited to, FDA, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements.
• 4 years of experience working on projects with plastic injection molding, textile, and/or converting part design and implementation. 
• 2 years of experience in single use disposable or reusable medical devices.
• 2 years of sterile facility development experience supporting ISO Classified clean rooms.