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Senior Mechanical Engineer
2 months ago
TalentBurst, an Inc 5000 company, is seeking a highly skilled Senior Mechanical Engineer to join our team. As a key member of our engineering team, you will be responsible for assisting in the update of component-level manufacturing documentation, working on Design for Manufacturing improvements, and improving overall manufacturing in support of ISO-13485 certification and IVDR Class A products.
Key Responsibilities- Review and Update Mechanical Drawings and Specifications: Ensure that all mechanical drawings and specifications are accurate, up-to-date, and compliant with regulatory requirements.
- Apply Sound Engineering Judgement to Complete Risk Assessments: Conduct thorough risk assessments to identify potential hazards and develop mitigation strategies.
- Determine Where and How to Apply Critical to Quality (CTQ) Inspection Criteria: Develop and implement CTQ inspection criteria to ensure that products meet quality and regulatory standards.
- Measure/Inspect Electromechanical Components for Form, Fit, and Function: Conduct thorough inspections of electromechanical components to ensure that they meet design specifications and regulatory requirements.
- Perform Robust Root Cause Analysis of Production Issues: Investigate and resolve production issues in a timely and effective manner.
- Process Change Orders within an eQMS: Manage change orders within our electronic quality management system (eQMS) to ensure that all changes are properly documented and approved.
- Communicate Effectively Both Verbally and in Writing: Develop and maintain effective communication with cross-functional teams, including engineering, manufacturing, and quality assurance.
- Bachelor's Degree in Mechanical Engineering: A degree in mechanical engineering or a related field is required.
- 5+ Years of Mechanical or Manufacturing Engineering Experience: A minimum of 5 years of experience in mechanical or manufacturing engineering, preferably in a regulated industry.
- Experience Utilizing SolidWorks and PDM for Design: Proficiency in SolidWorks and product data management (PDM) systems is required.
- Knowledge of QSR and ISO Regulations: Familiarity with QSR and ISO regulations is a plus.
- Good Written and Oral Communication Skills: Excellent written and oral communication skills are required to effectively communicate with cross-functional teams.
- Works Well in a Team, Proactive, Thrives in a Fast-Moving Environment: Ability to work effectively in a team environment, be proactive, and thrive in a fast-paced environment.
