Manufacturing Engineer

At MIMEDX, our purpose starts with helping humans heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care & surgical products, we are committed to making a transformative impact on the lives of patients we serve globally. Will you join us on this journey? We are excited to add a Manufacturing Engineer to our Operations ! This role will be a hybrid position. The position will pay between $74,000 - $105,000 based on previous relevant experience and educational credentials.

This position is responsible for identifying waste and bottlenecks in the manufacturing processes and then using engineering principles to make improvements to the systems to minimize those wastes. Responsible for keeping the production costs down while maintaining the quality and customer availability of the final product without compromising employee safety or regulatory compliance. Works with product development team to ensure that new manufacturing processes are safe, compliant, cost-efficient, and repeatable.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Interface with product development and quality engineering teams to ensure manufacturability of new products.
2. Develop and execute validation protocols in accordance with GMP and FDA compliance.
3. Write/update SOPs to incorporate new technology and methods and train manufacturing personnel on procedures.
4. Design equipment or recommend equipment purchases to support product development and manufacturing objectives.
5. Evaluate manufacturing practices to provide continuous improvement of processes.
6. Evaluate existing manufacturing processes and identify areas for improvement.
7. Conduct PFMEAs (Process Failure Mode Effects Analysis) as needed
8. Develop detailed layouts for equipment, processes, and workflow to optimize operational efficiency.
9. Research and develop new processes, equipment, and products.
10. Develop and implement cost-saving measures and quality system improvements.
11. Ensure manufacturing processes, equipment, and products comply with safety and regulatory standards.
12. Evaluate quality control processes and make recommendations for improvements in quality control.
13. Analyze production processes, schedules, methods and other data and then provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process.
14. Review and calculate labor, material and other production costs.
15. Analyze and process workflow, equipment placement, and space requirements to improve manufacturing efficiency.
16. Adhere to the policies and practices from the Quality Management System based on regulatory requirements for medical device manufacturing under FDA Quality System Regulation and/or ISO 13485 and contribute towards maintaining a safe work environment.
17. Any other duties that may be required or assigned.
18. 80% of work is done on the shop floor

EDUCATION/EXPERIENCE:

• BS degree in Industrial Engineering, Manufacturing Engineering, or Mechanical Engineering
• 3+ years of experience in manufacturing or industrial engineering preferred
• Experience in biomedical manufacturing and knowledge of Six Sigma Tools, GMP and ISO requirements related to manufacturing preferred

SKILLS/COMPETENCIES:

• Experience evaluating and troubleshooting manufacturing processes and machinery
• Experience using CAD, CAM, data analysis programs, and related software
• Excellent verbal and communication skills
• Strong organization and project management skills
• Proficiency in Microsoft Office
• Experience with the design and monitoring of key manufacturing performance indicators
• Strong analytical thinker with ability to creatively solve problems
• Ability to hit deadlines with quality results
• Teamwork skills
• Good information technology skills
• Commercial awareness

PHYSICAL DEMANDS:

• Frequent need to remain in a stationary position for at least 2 hours at a time with option to alternate sitting or standing at will.
• Frequent need to walk throughout facilities including entering/exiting CEAs
• Moderate need to use hands to obtain manufacturing and office materials
• Infrequent use of step ladders/ladders
• Moderate need to stoop or crouch in order to don CEA PPE and to observe manufacturing processes
• Frequent need to verbally communicate verbally in office and CEA environments
• Moderate need for near visual acuity for inspecting product quality including a full spectrum of color variations
• Frequent entering of text and data via a traditional keyboard
• Occasional lifting of raw materials and portable equipment <10 kg

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to, or requirements for, this job at any time.