Design Engineer

Aspen Surgical • Caledonia, MI

22d • Onsite

About The Position

The 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 lead projects and evaluate design changes related to existing products to maintain business continuity. You will develop and evaluate medical device designs that meet defined product requirements and are optimized for safe clinical solutions, production, reliability, and overall cost effectiveness for the business. You will execute medical device design history file activities to be compliant with applicable regulations. You will provide technical support to other departments and individuals as necessary in the exploration of new opportunities, complaints, etc. You will evaluate proposed changes to existing products and complete deliverables required to implement change through individual efforts or cross-functional teams. You will ensure product changes meet regulations as well as internal and external customer requirements. You will troubleshoot and problem-solve efforts related to product design and conduct thorough engineering and data analysis. You will manage project schedules, budgets, mitigating risks, and efficient solutioning of issues. You will communicate project plans, track tasks, and manage time to meet project deadlines. You will communicate with leaders the status of projects in a clear and efficient manner. You will work closely with the portfolio managers to understand clinical and commercial impacts. You will have strong communication skills to convey design concepts to clinicians to obtain design direction. You will 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. You will work with finance to develop product costing to understand impacts of material/design selections. You will 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
• 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.
• 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
• Business case development for product costing as it pertains to design
• Strong teamwork and effective communication to enhance a positive culture.
• Ability to effectively communicate and collaborate globally.
• Excellent computer skills including but not limited to Microsoft Office Suite
• Ability to travel up to 15% required.

Nice To Haves

• Preferred working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards
• Preferred involvement with invention disclosures or patents
• Preferred experience using engineering programs such as SolidWorks, Minitab, TOPS, similar.

Responsibilities

• 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.
• 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.
• Work closely with the portfolio managers to understand clinical and commercial impacts.
• 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.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level