Senior Medical Device Design Lead & Technical Authority

Stress Engineering Services, Inc.; Mason (OH); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

ESOP

Benefits package

Job summary

Stress Engineering Services seeks an Industrial Product Design Engineer to lead medical device programs, guiding concepts through commercialization in highly regulated settings. You will mentor engineers, oversee cross-functional teams, and act as a trusted advisor to clients developing surgical, drug delivery, diagnostics, and other healthcare devices.

The role emphasizes design controls, ISO 14971-based risk management, human factors, verification and validation, and manufacturability, with a

Qualifications

• ABET-accredited engineering degree required (B.S., M.S., or Ph.D.).
• PE license required and 15+ years in medical device development.
• Experience leading regulated product development and multi-discipline teams.
• Strong knowledge of FDA-regulated processes and Design Controls.

Responsibilities

• Lead medical device programs from concept through commercialization.
• Mentor engineers and guide multidisciplinary teams in regulated environments.
• Provide executive-level technical guidance and client advisory on development strategies.
• Oversee design reviews, risk assessments, and regulatory submissions.
• Develop prototypes, verification methods, and validation plans.

Skills

Technical leadership

Team mentoring

Client engagement

Design controls

Risk management

Human factors

V&V

DFM

DFA

Reliability engineering

PLM

Regulated environments

Education

ABET-accredited engineering degree

Tools

SolidWorks

Python

DOE

Minitab

MATLAB

Job description

Stress Engineering Services seeks an Industrial Product Design Engineer to lead medical device programs, guiding concepts through commercialization in highly regulated settings. You will mentor engineers, oversee cross-functional teams, and act as a trusted advisor to clients developing surgical, drug delivery, diagnostics, and other healthcare devices.

The role emphasizes design controls, ISO 14971-based risk management, human factors, verification and validation, and manufacturability, with a