SummaryThe Design Engineer is responsible for Designing 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:Medical Device Product Development- Lead projects and evaluate design changes related to existing products to maintain business continuity.
- Develop and evaluate medical device designs which meet defined product requirements and are optimized for safe clinical solutions, production, reliability, and overall cost effectiveness for the business.
- Execute medical device design history file activities to be compliant with applicable regulations.
- Provide technical support to other departments and individuals as necessary in the exploration of new opportunities, complaints etc.
- Evaluate proposed changes to existing products and complete deliverables required to implement change through individual efforts or cross-functional teams.
- Ensure product changes meet regulations as well as internal and external customer requirements.
- Troubleshoot and problem-solve efforts related to product design.
- Conduct thorough engineering and data analysis.
Project Management- Manage project schedules, budgets, mitigating risks, and efficient solutioning of issues.
- Communicate project plans, track tasks, and manage time to meet project deadlines.
- Communicate with leaders status of projects in a clear and efficient manner.
Global Collaboration- Work closely with the portfolio managers to understand clinical and commercial impacts.
- Strong communication skills to convey design concepts to clinicians to obtain design direction
- Work with manufacturing throughout the development phases to ensure that products are produced in a safe, efficacious, and quality manner while keeping within established time frames
- Work with finance to develop product costing to understand impacts of material/design selections
- Interface with vendors, manufacturing facilities, and various internal groups to resolve design and manufacturing issues of new and existing products.
What You Need to Succeed in This Position- Bachelor of Science Degree in Engineering is required
- A minimum of three to five years of medical device engineering experience
- Regulated industry experience that includes, but not limited to, FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements.
- Preferred working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards
- Strong familiarity with the methods of Risk Management and Failure Mode Effects Analysis (FMEA)
- Working knowledge of design history & technical file within an auditing environment.
- Working knowledge of statistical analysis of data used to meet or define design criteria
- Project management experience to effectively manage and complete multiple projects simultaneously
- Preferred involvement with invention disclosures or patents
- Business case development for product costing as it pertains to design
- Preferred experience using engineering programs such as SolidWorks, Minitab, TOPS, similar.
- Strong teamwork and effective communication to enhance a positive culture.
- Ability to effectively communicate and collaborate globally.
- Drives a culture of clinical safety and quality first.
- Mitigates risks during the lifetime of the projects
- Engage in continuous education to maintain job knowledge in medical device design & development
- Excellent computer skills including but not limited to Microsoft Office Suite
- Ability to travel up to 15% required.
