Medical Device Design Engineer — Global Impact Projects

Aspen Surgical; Michigan; Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

Aspen Surgical is seeking a Design Engineer to develop medical device designs that support growth, cost targets, and business continuity. You will lead projects, evaluate changes, and ensure regulatory compliance across the product lifecycle.

You will collaborate with portfolio managers, manufacturing, and finance to optimize cost, performance, and quality while maintaining timelines. Travel up to 15% may be required.

Formación

• Bachelor of Science Degree in Engineering is required.
• 3–5 years of medical device engineering experience.
• Regulated industry experience (FDA 21 CFR 820, ISO 13485, ISO 14971, MDSAP, EU MDR).
• Preferred familiarity with ISO 11607 and testing standards such as ASTM 4169.
• Strong knowledge of risk management and FMEA.

Responsabilidades

• Lead medical device design projects to maintain business continuity and meet product requirements.
• Develop and evaluate designs optimized for safety, production, reliability, and cost.
• Execute design history file activities to ensure regulatory compliance.
• Provide technical support across departments for opportunities, complaints, and changes.
• Collaborate with manufacturing, finance, and vendors to resolve design and manufacturing issues.
• Ensure product changes meet regulatory and customer requirements.
• Troubleshoot design-related issues and perform thorough data analysis.
• Manage multiple projects with scheduling and budgeting considerations.
• Travel up to 15% as required.

Conocimientos

Design engineering

Regulatory knowledge

Project management

Cross-functional collaboration

Communication skills

Travel willingness

Educación

Bachelor's degree in Engineering

Herramientas

SolidWorks

Minitab

TOPS

Descripción del empleo

Aspen Surgical is seeking a Design Engineer to develop medical device designs that support growth, cost targets, and business continuity. You will lead projects, evaluate changes, and ensure regulatory compliance across the product lifecycle.

You will collaborate with portfolio managers, manufacturing, and finance to optimize cost, performance, and quality while maintaining timelines. Travel up to 15% may be required.