Design Engineer

Aspen Surgical; Caledonia (MI); On-site; USD 80,000 - 120,000; Full time

Job summary

Aspen Surgical is seeking a Design Engineer to drive medical device development from concept through design history file, ensuring safety, reliability, and cost targets.

You will lead projects in collaboration with manufacturing, finance, and clinical staff, ensuring adherence to FDA/ISO standards and product quality throughout lifecycle.

Qualifications

• Bachelor of Science Degree in Engineering is required.
• A minimum of three to five years of medical device engineering experience.
• Regulated industry familiarity: FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP, and EU MDD/MDR requirements.
• Preferred knowledge: ISO 11607 and testing to ASTM 4169.
• Strong knowledge of Risk Management and FMEA.
• Experience with design history files and auditing environment.
• Statistical analysis skills for design criteria.
• Project management experience to handle multiple projects.
• Involvement with invention disclosures or patents preferred.
• Costing for product design.
• Experience with SolidWorks, Minitab, TOPS.

Responsibilities

• Lead projects and evaluate design changes to maintain business continuity.
• Develop and evaluate medical device designs meeting requirements for safe clinical use, production, reliability, and cost.
• Execute design history file activities to comply with regulations.
• Provide technical support across departments for opportunities and complaints.
• Evaluate changes and drive implementation via cross-functional teams.
• Ensure changes meet regulatory and customer requirements.
• Troubleshoot and resolve design-related issues.
• Conduct thorough engineering and data analysis.
• Manage project schedules and budgets; mitigate risks.
• Communicate project plans and status to leaders.
• Collaborate with portfolio managers on clinical and commercial impacts.
• Convey design directions to clinicians to obtain input.
• Coordinate with manufacturing to ensure safe, efficacious production within timelines.
• Work with finance on product costing impacts.
• Interface with vendors and manufacturing facilities to resolve issues.

Skills

Communication

Project management

Teamwork

Global collaboration

Clinical safety & quality

Data analysis

Education

Bachelor of Science in Engineering

Tools

SolidWorks

Minitab

TOPS

Job description

We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people’s lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.

Summary

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.
• 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.
• Strongteamwork 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.

We're proud to be an equal opportunity employer-and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.