Senior Manager, Medical Device Design & Engineering

Stress Engineering Services, Inc.; Mason (OH); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Employee-owned culture (ESOP)

Thought Leadership

Job summary

Stress Engineering Services (SES) seeks a Manager of the Mechanical Design Engineering team focused on medical device and healthcare product development. You will lead multidisciplinary teams, guide clients through complex regulatory landscapes, and mentor engineers across surgical devices, drug delivery, diagnostics, and related healthcare technologies.

As a senior technical authority, you will oversee projects from concept through verification, validation, regulatory submissions, manufacturing

Qualifications

• Bachelor’s, Master’s, or PhD in Mechanical or Biomedical Engineering from ABET-accredited institution.
• PE license required.
• 15+ years of progressive experience developing medical devices in regulated environments.
• Experience leading product development programs from concept through commercialization.
• Demonstrated FDA-regulated product development & Design Controls expertise.
• Experience leading multidisciplinary engineering teams and mentoring professionals.
• Strong risk management, verification/validation, and quality systems knowledge.
• Proven client engagement and technical leadership.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Serve as a senior technical authority for medical device and healthcare product development programs.
• Lead and mentor engineers, fostering innovation, excellence, accountability, and learning.
• Provide oversight on complex client engagements across devices, drug delivery, diagnostics, and combination products.
• Guide teams through design decisions, risk assessments, and regulatory requirements.
• Perform high-level design reviews throughout the product development lifecycle.
• Support recruitment and development of future technical leaders within SES.
• Lead cross-functional product development activities and regulatory submissions.

Education

ABET-accredited Mechanical or Biomedical Engineering

Professional Engineer (PE) license

15+ years medical device development experience

Tools

SolidWorks

Python

MATLAB

Minitab

JMP

Job description

Stress Engineering Services (SES) seeks a Manager of the Mechanical Design Engineering team focused on medical device and healthcare product development. You will lead multidisciplinary teams, guide clients through complex regulatory landscapes, and mentor engineers across surgical devices, drug delivery, diagnostics, and related healthcare technologies.

As a senior technical authority, you will oversee projects from concept through verification, validation, regulatory submissions, manufacturing