Senior Engineer SE}

ARCH • Olive Branch, MS

3d

About The Position

Plays a critical role in leading the design, development, and optimization of medical devices. This position requires extensive technical expertise, project management skills, and the ability to mentor junior engineers. The Senior Engineer ensures that all products meet regulatory standards and quality expectations, driving innovation and continuous improvement within the organization. This role requires 7-10 years of extensive quoting experience and design for manufacturing experience specific to complex medical instrumentation, devices, and implants.

Requirements

• Education: Bachelor/Masters degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, preferred or equivalent experience.
• Experience: Minimum of 5-10 years of engineering experience in the medical device manufacturing industry, with a proven track record of leading successful projects.
• Technical Skills: Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools. Deep understanding of ISO 13485, FDA regulations, and other relevant standards.
• Project Management: Strong project management skills, with the ability to manage multiple projects simultaneously. Experience with project management software is a plus.
• Analytical Skills: Excellent analytical and problem-solving abilities. Capable of performing complex analysis and interpreting data to make informed decisions.
• Communication: Superior written and verbal communication skills. Ability to clearly document and present technical information to diverse audiences.
• Leadership: Demonstrated leadership and mentorship capabilities. Ability to inspire and guide a team of engineers toward achieving common goals.
• Attention to Detail: High level of attention to detail with a commitment to delivering high-quality work.

Responsibilities

• Project Leadership: Lead and manage complex engineering projects from concept through production, ensuring timely delivery and compliance with industry standards and regulations.
• Design and Development: Develop innovative medical devices and components, utilizing advanced engineering principles and practices. Oversee the entire product lifecycle, from initial design through to manufacturing and post-market support.
• Regulatory Compliance: Ensure all engineering activities adhere to relevant regulatory requirements, including ISO 13485 and FDA regulations. Prepare and review technical documentation to support regulatory submissions.
• Quality Assurance: Implement and maintain robust quality control systems. Conduct detailed analysis and testing to validate product performance and reliability. Address and resolve any quality issues that arise during development and production.
• Mentorship: Provide technical guidance and mentorship to junior engineers. Foster a collaborative and supportive team environment that encourages professional growth and development.
• Process Improvement: Identify opportunities for process improvements and lead initiatives to enhance product quality, manufacturing efficiency, and overall operational effectiveness.
• Cross-Functional Collaboration: Work closely with R&D, quality assurance, production, and other departments to ensure seamless integration of new products into manufacturing processes. Facilitate effective communication and collaboration across teams.
• Technical Expertise: Stay current with industry trends, emerging technologies, and regulatory changes. Apply this knowledge to drive innovation and maintain the company’s competitive edge.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level