Description: 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 implementing automation and robotics, leading cost-saving projects, and launching new products into manufacturing.
Key Responsibilities:
Develop, implement, and optimize manufacturing processes for medical devices to ensure high quality and efficiency.
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.
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Contact: pbyrne@judge.com
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