Engineer jobs in United States

We are seeking a skilled Medical Device Process Engineer to join our team. This role involves designing, developing, and optimizing manufacturing processes for medical devices, ensuring compliance with industry regulations and quality standards.

• Develop and optimize manufacturing processes for medical devices, focusing on efficiency, quality, and safety.
• Collaborate with R&D, quality assurance, and production teams to ensure seamless transition from design to manufacturing.
• Conduct process validations and perform risk assessments to identify and mitigate potential issues.
• Analyze production data to identify trends and areas for improvement.
• Implement process control strategies to maintain product quality and consistency.
• Prepare and maintain documentation for process specifications, work instructions, and standard operating procedures.
• Lead root cause analysis and corrective action initiatives for process-related issues.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related field.
• 3+ years of experience in process engineering within the medical device or related industry.
• Strong knowledge of FDA regulations, ISO standards, and quality systems.
• Proficiency in statistical process control (SPC) and process improvement methodologies (e.g., Six Sigma, Lean).
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork abilities.

• Experience with CAD software and process simulation tools.
• Familiarity with materials used in medical device manufacturing.
• Project management experience is a plus.

This role offers the opportunity to impact the design and manufacturing of cutting-edge medical devices. If you are passionate about improving processes and ensuring product quality, we encourage you to apply!