Senior Principal, Medical Device Design & Development

Stress Engineering Services Inc.; Mason (OH); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Paid time off and holidays

Employee-owned culture (ESOP)

Job summary

Stress Engineering Services (SES) seeks an accomplished Industrial Product Design Engineer to lead medical device development programs from concept to commercialisation. You will mentor teams, guide regulatory submissions, and serve as a trusted advisor to clients across surgical devices, diagnostics, and drug delivery systems.

The role requires deep mechanical design expertise, risk management, and experience in FDA-regulated environments.

Qualifications

• Bachelor's, Master's, or PhD in Mechanical or Biomedical Engineering from ABET-accredited institution.
• Professional Engineer (PE) license is required.
• 15+ years of experience developing medical devices in regulated environments.
• Experience leading product development from concept through commercialization.
• Strong knowledge of FDA-regulated development processes and Design Controls.
• Proven leadership of multidisciplinary teams and client engagements.
• Excellent written, verbal, and presentation skills.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Lead multidisciplinary teams and mentor engineers on medical device programs.
• Provide technical oversight on complex client engagements across devices and diagnostic products.
• Guide projects from concept through verification, validation, and regulatory submissions.
• Conduct high-level design reviews and risk assessments.
• Support business development and build long-term client relationships.

Skills

Technical leadership

Medical device design

Regulatory knowledge

FDA standards

Mentoring

Client engagement

Design Controls

Risk management

Project leadership

Education

ABET-accredited degree in Mechanical or Biomedical Engineering

Professional Engineer (PE) license

PhD (advanced degree) in related field

Tools

SolidWorks

Python

MATLAB

Minitab

JMP

Job description

Stress Engineering Services (SES) seeks an accomplished Industrial Product Design Engineer to lead medical device development programs from concept to commercialisation. You will mentor teams, guide regulatory submissions, and serve as a trusted advisor to clients across surgical devices, diagnostics, and drug delivery systems.

The role requires deep mechanical design expertise, risk management, and experience in FDA-regulated environments.