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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Design Engineer - **Company:** ASPEN SURGICAL, LLC - **Location:** Caledonia, MI, United States - **Experience:** Experienced - **Contract:** Permanent contract - **Skills:** Data Analysis, SolidWorks (CAD), Failure Mode Effects Analysis, Microsoft Office, Minitab, Mdsap - **Published:** July 26, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=7c5faaa8f8dca22c ## About the Role * 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. ## Description 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: 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. ## Related Videos - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [The Innovation Formula: Fast Prototyping, Data Analysis, and Real User Insights](https://www.wearedevelopers.com/videos/1421-the-innovation-formula-fast-prototyping-data-analysis-and-real-user-insights) ## Related Articles - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Software Engineer Career: Things You Should Know](https://www.wearedevelopers.com/magazine/143-software-engineer-career-things-you-should-know) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [What Jobs Can You Get with a Software Engineering Degree?](https://www.wearedevelopers.com/magazine/398-what-jobs-can-you-get-with-a-software-engineering-degree)