Design Engineer (Sustaining)

Aspen Surgical; Caledonia (MI); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Aspen Surgical in Michigan is seeking a Design Engineer to design medical devices that support growth, cost efficiency, and business continuity. You will lead design changes, develop robust solutions, and ensure regulatory compliance across the product lifecycle.

You will collaborate with portfolio managers, manufacturing, and quality teams to translate clinical needs into manufacturable designs, analyze risk, and manage projects to meet timeframes while maintaining safety and efficacy.

Competenze

• Bachelor of Science Degree in Engineering is required.
• 3–5 years of medical device engineering experience.
• Regulated industry experience: FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP, EU MDR.
• Knowledge of ISO 11607 and transit testing to ASTM 4169.
• Familiarity with Risk Management and FMEA.
• Experience with design history file and auditing.
• Statistical analysis to meet design criteria.
• Project management experience to manage multiple projects.
• Experience with SolidWorks, Minitab, TOPS.
• Strong teamwork and communication.
• Travel up to 15%.

Mansioni

• Lead projects and evaluate design changes to maintain business continuity.
• Develop and evaluate medical device designs optimized for safety, production, reliability and cost.
• Execute design history file activities to be regulatory compliant.
• Provide technical support to other departments for new opportunities and issues.
• Evaluate proposed changes and implement via cross-functional teams.
• Ensure changes meet regulations and customer requirements.
• Troubleshoot and problem-solve design issues.
• Conduct engineering and data analysis.

Conoscenze

Medical device design

Project management

Risk Management & FMEA

Strong communication

Global collaboration

Formazione

Bachelor of Science in Engineering

Strumenti

SolidWorks

Minitab

TOPS

Descrizione del lavoro

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 tomaintainbusiness 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.