Senior Medical Device Design Engineer | Growth & Compliance

Talent Reel; Caledonia (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Aspen Surgical in Caledonia, MI is seeking a Sr Design Engineer to design and develop medical devices, ensuring regulatory compliance and cost efficiency. You will lead design history files, perform data analysis, and collaborate with manufacturing, quality, and clinical teams to translate requirements into robust product solutions.

This on-site role includes travel up to 15% and interaction with global teams.

Qualifications

• Bachelor's degree in engineering or closely related field.
• 7+ years of medical device engineering experience preferred.
• Experience with regulatory frameworks and design controls.

Responsibilities

• Design and develop medical devices with a focus on safety, reliability, and cost effectiveness.
• Execute design history file activities to meet regulatory requirements.
• Collaborate with cross-functional teams to drive product development timelines.
• Provide technical guidance to manufacturing and quality functions.
• Assess proposed design changes and implement through cross-functional teams.
• Ensure product changes comply with regulatory and customer requirements.
• Troubleshoot design issues and perform data analysis.
• Work with portfolio managers and finance on cost considerations.

Skills

Medical device engineering

Project management

Regulatory knowledge

SolidWorks

FMEA

Communication skills

Team collaboration

Education

Bachelor of Science in Engineering

Tools

SolidWorks

Minitab

TOPS

Excel

Job description

Aspen Surgical in Caledonia, MI is seeking a Sr Design Engineer to design and develop medical devices, ensuring regulatory compliance and cost efficiency. You will lead design history files, perform data analysis, and collaborate with manufacturing, quality, and clinical teams to translate requirements into robust product solutions.

This on-site role includes travel up to 15% and interaction with global teams.