Design Engineer (Sustaining)

Aspen Surgical•Caledonia, MI

About The Position

The Design Engineer is responsible for designing medical devices that support the growth, cost profile, and business continuity of Aspen Surgical products. The role works in a collaborative team environment and leads projects and evaluates design changes for existing products. It develops and evaluates designs that meet defined product requirements and support safe clinical solutions, production, reliability, and cost effectiveness. The position also completes design history file activities to comply with applicable regulations, provides technical support, evaluates and implements product changes, troubleshoots design issues, and conducts engineering and data analysis. The Design Engineer manages project schedules, budgets, risks, issues, tasks, and deadlines, and communicates project status clearly to leaders. The role collaborates globally with portfolio managers, clinicians, manufacturing, finance, vendors, manufacturing facilities, and internal groups to understand clinical and commercial impacts, obtain design direction, support product costing, and resolve design and manufacturing issues. It works with manufacturing throughout development to help ensure products are safe, efficacious, and high quality within established time frames. Travel up to 15% is required.

Requirements

Bachelor of Science degree in Engineering.
Three to five years of medical device engineering experience.
Regulated-industry experience, including applicable requirements such as FDA 21 CFR 820.30, ISO 13485, ISO 14971, MDSAP, and European MDD/MDR.
Strong familiarity with risk management methods and Failure Mode and Effects Analysis (FMEA).
Working knowledge of design history files and technical files in an auditing environment.
Working knowledge of statistical analysis of data used to meet or define design criteria.
Project management experience managing and completing multiple projects simultaneously.
Strong teamwork and effective communication skills.
Ability to communicate and collaborate globally.
Excellent computer skills, including Microsoft Office Suite.
Ability to travel up to 15%.

Nice To Haves

Working knowledge of ISO 11607 regulations and transit testing to ASTM D4169 or similar standards.
Involvement with invention disclosures or patents.
Experience developing business cases for product costing as it pertains to design.
Experience with engineering programs such as SolidWorks, Minitab, or TOPS.

Responsibilities

Lead projects and evaluate design changes for existing products to maintain business continuity.
Develop and evaluate medical device designs that meet product requirements and are optimized for clinical safety, production, reliability, and cost effectiveness.
Complete medical device design history file activities in compliance with applicable regulations.
Provide technical support to other departments and individuals in exploring new opportunities and addressing complaints.
Evaluate proposed changes to existing products and complete deliverables needed to implement them, individually or with cross-functional teams.
Ensure product changes meet regulatory requirements and internal and external customer requirements.
Troubleshoot product design problems and conduct engineering and data analysis.
Manage project schedules, budgets, risks, issues, tasks, and deadlines.
Communicate project plans and project status clearly and efficiently to leaders.
Work with portfolio managers to understand clinical and commercial impacts.
Communicate design concepts to clinicians to obtain design direction.
Collaborate with manufacturing throughout development to support safe, efficacious, high-quality products within established time frames.
Work with finance to develop product costing and understand the impact of material and design selections.
Interface with vendors, manufacturing facilities, and internal groups to resolve design and manufacturing issues for new and existing products.
Maintain job knowledge through continuous education in medical device design and development.
Promote clinical safety and quality, and mitigate risks throughout projects.