Principal Mechanical Engineer

Duties & Responsibilities

Contribute to planning through all project phases with a focus on the change control strategy, development of design verification strategies, and execution of said strategies.
Support technical gap assessments, development of remediation plans, and execution of said plans.
Craft, edit, and interpret technical drawings and write protocols, reports, work instructions, presentations, etc.
Apply engineering principles for design/analysis and complete statistical analysis and sample plan development.
Demonstrate accountability for the successful and timely achievement of goals.

Experience Required

• Minimum 3 years of experience in medical device or other regulated industry
• Experience with design controls activities and change management including DHF documentation is required
• Experience with technical gap assessments and remediation strategy development / execution is required
• Experience with test method development, validation strategy, and execution is required.
• Experience with design verification strategy development and execution is required
• Proficiency in solid mechanics/mechanics of materials and experience to statistical methods / tools is required.
• Experience in solid modeling (SolidWorks or equivalent) is desirable

Skills & Certifications

• Work independently with minimal guidance to complete objectives assigned by project team

Eligibilities & qualifications

Bachelors Degree