Senior Medical Device Design Leader

Stress Engineering Services, Inc.; Mason (OH); On-site; USD 150,000 - 195,000; Full time

Job summary

Stress Engineering Services seeks a Manager of the Mechanical Design Engineering team focused on medical device and healthcare product development. This senior consulting role leads multidisciplinary teams, mentors engineers, and serves as a trusted advisor to clients creating next‑gen medical devices and diagnostics through concept to commercialization.

The ideal candidate has extensive FDA‑regulated product development experience, strong design controls, and a proven ability to drive risk

Qualifications

• Bachelor's, Master's, or PhD in Mechanical Engineering, Biomedical Engineering, or related engineering discipline from an ABET‑accredited institution.
• Professional Engineer (PE) license required.
• 15+ years of progressive experience developing medical devices within regulated environments.
• Extensive experience leading product development programs from concept through commercialization.
• Demonstrated expertise in FDA‑regulated product development processes and Design Controls.
• Experience leading multidisciplinary engineering teams and mentoring technical professionals.
• Strong understanding of product risk management, verification, validation, and quality systems.
• Proven track record of successful client engagement and technical leadership.
• Exceptional written, verbal, and presentation skills.

Responsibilities

• Lead multidisciplinary teams and mentor engineers, fostering innovation and excellence.
• Guide projects from concept through verification, validation, regulatory submissions, and commercialization.
• Provide technical oversight on complex client engagements across medical devices and drug delivery systems.
• Conduct high‑level design reviews and risk assessments throughout development lifecycle.
• Engage with clients at executive levels to discuss strategies, testing approaches, and commercialization plans.
• Support recruiting and development of future technical leaders within SES.

Skills

Technical leadership

People leadership

Client engagement

Design reviews

Regulatory compliance

Risk management

Human factors

FDA processes

CAD proficiency

Mentoring engineers

Education

ABET‑accredited degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Python

MATLAB

DOE

Job description

Stress Engineering Services seeks a Manager of the Mechanical Design Engineering team focused on medical device and healthcare product development. This senior consulting role leads multidisciplinary teams, mentors engineers, and serves as a trusted advisor to clients creating next‑gen medical devices and diagnostics through concept to commercialization.

The ideal candidate has extensive FDA‑regulated product development experience, strong design controls, and a proven ability to drive risk