Principal Mechanical Design Engineer

engineeringjobs.net, Inc.; California (MO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Coverage

Paid Leave

Job summary

engineeringjobs.net, Inc. seeks a senior leader to drive mechanical product development for implantable and wearable medical devices from concept through commercial release.

You will guide verification, validation, failure analysis, and manufacturing readiness while mentoring engineers and coordinating with suppliers and stakeholders. Requirements include a bachelor’s degree in mechanical/biomedical engineering and 8+ years in medical device product development with commercialization experience;

Qualifications

• Requires a bachelor's degree in mechanical engineering, biomedical engineering, or related field with 8+ years of medical device product development and commercialization experience.
• Experience with electromechanical development, design controls, and verification & validation; leadership skills.
• Implantable device experience and master's degree preferred.

Responsibilities

• Lead mechanical product development for implantable and wearable devices from concept to commercial release.
• Guide verification, validation, failure analysis, and manufacturing readiness activities.
• Mentor engineers and coordinate with suppliers and stakeholders across cross-functional teams.
• Ensure regulatory compliance (FDA/ISO) throughout product development and launches.

Skills

Mechanical Product Development

Electromechanical Systems

Medical Device Development

Technical Leadership

Product Requirements

Technical Specifications

Design Reviews

Verification and Validation

Failure Analysis

Manufacturing Readiness

FDA and ISO Compliance

Design Controls

Risk Management

FMEA

Education

Bachelor's degree in Mechanical Engineering

Master's degree (preferred)

Tools

Creo

SolidWorks

Job description

Lead mechanical product development for implantable and wearable medical devices from concept through commercial release, guiding technical decisions and cross-functional execution. Support verification, validation, failure analysis, manufacturing readiness, regulatory compliance, and product launches while mentoring engineers and coordinating with suppliers and stakeholders.

Requirements:

• Requires a bachelor's degree in mechanical engineering, biomedical engineering, or a related discipline, plus at least eight years of medical device product development experience and a record of leading products through commercialization.
• Candidates should have electromechanical development experience, proficiency with Creo and/or SolidWorks, knowledge of design controls and verification and validation, and demonstrated technical leadership; implantable device experience and a master's degree are preferred.

Key Skills:

• Mechanical Product Development
• Electromechanical Systems
• Medical Device Development
• Technical Leadership
• Product Requirements
• Technical Specifications
• Design Reviews
• Verification and Validation
• Failure Analysis
• Manufacturing Readiness
• FDA and ISO Compliance
• Design Controls
• Creo
• SolidWorks
• Risk Management
• FMEA

Benefits:

• Medical Insurance
• Dental Insurance
• Vision Coverage
• Paid Leave