Manufacturing Engineer (Medical Device)

We are seeking a highly skilled and innovative Manufacturing Engineer. The ideal candidate will have extensive experience in medical device manufacturing and a proven track record of driving the product development pipeline.

Key Responsibilities:

• Develop, implement, and optimize manufacturing processes for medical devices to ensure high quality and efficiency.
• Be the voice of the customer internally and the voice of the company externally.
• Lead projects to introduce automation and robotics into the manufacturing process to improve productivity and reduce costs.
• Identify and implement cost-saving initiatives without compromising product quality or compliance.
• Collaborate with cross-functional teams, including R&D, quality, and production, to successfully launch new products into manufacturing.
• Conduct process validation and verification activities to ensure compliance with regulatory requirements.
• Analyze production data to identify trends, troubleshoot issues, and implement corrective actions.
• Develop and maintain documentation for manufacturing processes, including work instructions, process flow diagrams, and validation protocols.
• Train and mentor production staff on new processes and equipment.
• Participate in internal and external audits to ensure compliance with industry standards and regulations.

Qualifications:

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, or a related field.
• Minimum of 3-5 years of experience in manufacturing engineering within the medical device industry.
• Proven experience with automation and robotics in a manufacturing setting.
• Demonstrated success in leading cost-saving projects and initiatives.
• Experience in launching new products into manufacturing.
• Strong understanding of regulatory requirements and quality standards for medical devices (e.g., ISO 13485, FDA regulations).Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team in a fast-paced environment.