Senior Manufacturing Engineer - Judge Group

Role Title: Senior Manufacturing Engineer

Work Location: Eagan, MN (Fully On-site)

Duration: Direct Hire

Overview:

Our client is seeking a full-time Senior Manufacturing Engineer to join their team on-site in Eagan, MN. The ideal candidate will have extensive experience in the medical device industry, particularly in R&D and automation. This role involves overseeing manufacturing processes, implementing engineering techniques, and optimizing machining operations.

Responsibilities:

• Process Design and Optimization: Lead the design, development, and optimization of manufacturing processes to enhance efficiency, quality, and cost-effectiveness.
• Equipment and Tooling: Oversee the selection, installation, and validation of manufacturing equipment and tooling, ensuring efficient operation and maintenance.
• Process Validation: Develop and implement comprehensive process validation protocols (IQ/OQ/PQ) to meet regulatory and quality standards.
• Data Analysis: Analyze production data to identify trends, root causes of issues, and opportunities for improvement. Implement corrective actions as needed.
• Continuous Improvement: Lead initiatives using Lean, Six Sigma, and other methodologies to enhance processes and reduce waste.
• Collaboration: Work closely with cross-functional teams, including R&D, quality assurance, and production, to resolve technical issues and support new product introductions.
• Documentation: Maintain detailed documentation of manufacturing processes, including process flow diagrams, work instructions, and validation reports.
• Training and Mentorship: Provide technical guidance, training, and mentorship to junior engineers and production staff.
• Compliance: Ensure all manufacturing processes comply with relevant safety, quality, and regulatory standards, including FDA and ISO requirements.
• Project Management: Manage multiple projects simultaneously, ensuring timely completion within budget and quality standards.

Qualifications:

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related field (Master’s degree preferred)
• Proficiency in CAD software, statistical analysis, and process optimization
• Strong analytical and problem-solving skills
• Excellent communication and teamwork abilities
• Proven project management skills
• High attention to detail
• Demonstrated leadership skills and the ability to mentor and train junior engineers
• Ability to work independently and manage multiple projects in a fast-paced environment
• Experience in the medical device industry
• R&D and automation experience
• At least 5 years of relevant experience
• Positive attitude, high energy, and a willingness to take on more responsibilities