Design Engineer (Sustaining)

Talent Acquisition Team•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, working in a collaborative team environment. The role leads projects and evaluates changes to existing products, develops designs that meet requirements and support clinical safety, production, reliability, and cost effectiveness, and completes design history file activities to comply with applicable regulations. The position provides technical support, evaluates proposed product changes, ensures changes meet regulatory and customer requirements, troubleshoots design issues, and conducts engineering and data analysis. It also manages project schedules, budgets, risks, tasks, and communications, and collaborates globally with portfolio managers, clinicians, manufacturing, finance, vendors, and internal groups to address clinical, commercial, costing, design, and manufacturing needs. Travel of 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 FDA 21 CFR 820.30, ISO 13485, ISO 14971, MDSAP, and European MDD/MDR requirements.
Strong familiarity with risk management methods and Failure Mode Effects Analysis (FMEA).
Working knowledge of design history and technical files within 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.
Ability to travel up to 15%.
Excellent computer skills, including Microsoft Office Suite.

Nice To Haves

Working knowledge of ISO 11607 regulations and transit testing to ASTM 4169 or similar testing 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, TOPS, or similar.

Responsibilities

Lead projects and evaluate design changes related to existing products to maintain business continuity.
Develop and evaluate medical device designs that meet defined product requirements and are optimized for safe clinical solutions, production, reliability, and cost effectiveness.
Execute 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 changes, individually or through cross-functional teams.
Ensure product changes meet regulatory requirements and internal and external customer requirements.
Troubleshoot and problem-solve product design issues.
Conduct engineering and data analysis.
Manage project schedules, budgets, risks, and resolution of issues.
Communicate project plans, track tasks, and manage time to meet project deadlines.
Communicate project status clearly and efficiently to leaders.
Work with portfolio managers to understand clinical and commercial impacts.
Convey design concepts to clinicians to obtain design direction.
Work with manufacturing throughout development to support safe, efficacious, quality products delivered within established time frames.
Work with finance to develop product costing and understand the impacts of material and design selections.
Interface with vendors, manufacturing facilities, and internal groups to resolve design and manufacturing issues for new and existing products.
Mitigate risks during the lifetime of projects.
Engage in continuous education to maintain job knowledge in medical device design and development.