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Senior Mechanical Engineer
2 months ago
We are looking for a skilled and proactive Mechanical Engineer to contribute to our engineering initiatives. This position plays a crucial role in product innovation, production processes, and service support by utilizing advanced engineering principles. You will thrive in a collaborative and fast-paced environment where your insights and teamwork will significantly impact the organization.
Key Responsibilities:
- Engineering Program Development: Create and uphold programs for the systematic assessment and monitoring of projects, services, or facilities to ensure compliance with quality standards.
- Process Optimization: Identify and establish effective systems for process control in product development and manufacturing to satisfy both internal and external requirements.
- Leadership: Guide, mentor, and coach junior engineers and technicians to enhance their competencies in mechanical engineering.
- Issue Resolution: Spearhead the investigation and resolution of product and process discrepancies through systematic problem-solving techniques.
- Product Testing: Collaborate with design teams to ensure thorough product testing and validation.
- Risk Management: Oversee the execution and upkeep of risk assessments, ensuring product safety and effectiveness.
- Continuous Improvement: Implement and champion methodologies for product and process enhancement, including Six Sigma and Lean principles.
- Data Evaluation: Design and execute experiments for process refinement, meticulously documenting plans, protocols, and findings.
Required Qualifications:
- Education: Bachelor’s degree in Engineering or a related technical field, or equivalent experience.
- Experience: 2-5 years of engineering experience, demonstrating proficiency with quality tools and methodologies.
- Regulatory Acumen: Comprehensive understanding of industry regulations and standards.
- Skills: Strong project management, leadership, communication, and analytical skills.
- Tools & Techniques: Familiarity with Six Sigma, Lean methodologies, and process improvement strategies.
- Collaboration: Ability to work effectively in a diverse and matrixed environment, contributing both independently and as part of a team.
- Travel: Occasional travel may be necessary.
Preferred Qualifications:
- Advanced Education: Master’s degree in Engineering or a related discipline.
- Certifications: Relevant professional certifications in quality engineering.
- Industry Experience: Previous experience in the medical device sector, particularly with catheter products.
- Specialized Knowledge: Familiarity with the Structural Heart domain, including heart valves and delivery systems, is advantageous.
Essential Skills for Success:
- Engineering Expertise: Strong background in mechanical engineering with experience in biomedical or manufacturing fields.
- Detail Orientation: High level of precision and thoroughness in executing engineering tasks.
- Flexibility: Ability to adapt to rapidly changing priorities and manage multiple tasks effectively in a high-pressure setting.
- Quality Reporting: Experience with quality process documentation and non-conformance reporting.