Design Engineer

About the role

Design Engineer 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.

Responsibilities

• Lead medical device product development 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 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.
• Manage project schedules, budgets, mitigate risks, and efficiently resolve issues.
• Communicate project plans, track tasks, and manage time to meet project deadlines.
• Work closely with portfolio managers to understand clinical and commercial impacts.
• Convey design concepts to clinicians to obtain design direction.
• Collaborate with manufacturing throughout the development phases to ensure products are produced safely, efficaciously, and with quality 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.

Requirements

• Bachelor of Science Degree in Engineering is required.
• Minimum of three to five years of medical device engineering experience.
• Regulated industry experience that includes, but is 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, or 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.