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
Nice-to-Haves:
Leadership/mentorship experience, with potential to oversee a technician and intern
Lean Six Sigma Black Belt certification or equivalent
Contact: kgregor@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
