Manufacture Engineer - Intellectt INC

Hello,

One of my clients is currently looking for a Manufacturing Engineer, If you're interested or if your skills align with the role, please share your updated resume with me at sushma@intellectt.com.

Job Title: Manufacturing Engineer

Duration: 12 Months

Location: Chicago, IL | Minnesota, MN | Syracuse, NY | Alameda, CA | Boston, MA

Note: NO C2C

Job Description:

As a Manufacturing Engineer in the medical device industry, you will be responsible for ensuring the efficient production of medical devices while maintaining the highest standards of quality, safety, and regulatory compliance. You will collaborate with design teams, production staff, and quality assurance teams to optimize manufacturing processes, troubleshoot issues, and implement continuous improvements to meet product specifications and customer requirements.

Key Responsibilities:

• Develop, implement, and optimize manufacturing processes for medical devices.
• Analyze and improve production workflows to enhance efficiency, reduce waste, and maintain high-quality standards.
• Collaborate with product development teams to ensure manufacturability of new medical devices and ensure compliance with regulatory requirements (FDA, ISO 13485, etc.).
• Design and implement process improvements, automation, and tooling to enhance productivity.
• Develop and maintain technical documentation, including work instructions, SOPs, and process validation reports.
• Conduct root cause analysis and troubleshoot production issues to identify solutions and prevent recurrence.
• Perform validation activities for new processes and equipment.
• Monitor production metrics and KPIs to track performance and identify areas for improvement.
• Ensure adherence to quality control standards, including FDA regulations and ISO 13485.
• Train production personnel on new processes, equipment, and best practices.
• Support product transfers from R&D to manufacturing and provide input during design reviews.

Required Skills and Qualifications:

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
• At least 3-5 years of experience in manufacturing engineering, ideally within the medical device industry.
• Strong knowledge of manufacturing processes, including machining, injection molding, assembly, and testing for medical devices.
• Familiarity with regulatory standards such as FDA, ISO 13485, GMP, and other industry-specific standards.
• Experience with process optimization, Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Proficiency in CAD software (e.g., SolidWorks) for process and tooling design.
• Strong problem-solving and troubleshooting skills.
• Ability to work cross-functionally with teams in design, quality, and production.
• Excellent communication skills and attention to detail.
• Knowledge of risk management techniques (e.g., FMEA, CAPA) is a plus.
• Experience with computer-aided manufacturing (CAM) and ERP systems is beneficial.

Preferred Qualifications:

• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Experience with automated manufacturing equipment and robotics.
• Knowledge of product lifecycle management (PLM) software.
• Experience with validation and qualification processes (IQ, OQ, PQ).