Product Development Engineer

At MIMEDX, our purpose starts with helping patients 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 combined with a promising clinical pipeline, we are committed to making a transformative impact on the lives of patients we serve globally.

We are excited to add a Product Development Engineer to our R&D team! The position will pay between $93,000 - $128,000 with bonus based on previous relevant experience, educational credentials, and location.

POSITION SUMMARY:

The Product Development Engineer will support the operation of the Product Development group. Candidate will be responsible for new product development and sustaining engineering activities by designing and executing protocols and test methods. Data interpretation will be required. Delegated tasks and procedures are expected to be completed independently in a thorough and timely manner and documented in a comprehensive report to communicate the findings to Senior Product Development staff and possibly cross-functional teams. Candidate should possess an understanding of biology/chemistry and engineering principles.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Research, develop, design, and optimize innovative materials, components, assemblies, processes, and equipment for biological starting materials, tissue-based products, and implantable medical devices under 361 HCT/P (21 CFR Part 1271) and medical device (21 CFR Parts 800-1299) regulatory frameworks
• Draft, review, and update SOPs, material specifications, and work instructions to support tissue processing and medical device manufacturing
• Document (Outputs) in accordance with FDA regulations, process mapping, product & process risk analysis, work instructions, product drawings (2D/3D), detailed research and development in lab notebook
• Assist in translating user needs into engineering specifications and manufacturing requirements.
• Conduct feasibility studies and prototype evaluations to verify the functionality and compatibility of new products and manufacturing methods
• Apply limited analytical techniques to assess interaction of materials with biological systems or coordinating research efforts with internal resources or outside laboratories
• Influence material selection decisions for new product development efforts
• Support the implementation of process improvements to enhance product quality, consistency, and regulatory compliance.
• Use SolidWorks to design simple fixtures, testing apparatus, and manufacturing equipment to support product development efforts
• Function as PD representative on project teams to coordinate product development activities with various departments, outside consultants, contractors and suppliers
• Adheres to policies and practices from the Quality Management System based on Company standards and regulatory standards for tissue processing and medical devices
• Understands and adheres to the Company's standards regarding the protection of intellectual property, confidential/proprietary information and trade secrets
• Interfaces with internal departments to ensure Lab maintenance is performed and well-coordinated with other key functional areas
• Communicates with external departments to facilitate the implementation of new processes, process improvements or test methods
• Interacts professionally and effectively with other team members and departments

EDUCATION/EXPERIENCE/SKILLS/COMPETENCIES:

BS/BA in relevant discipline and 5+ year of experience in related field, or equivalent work experience

OR

MS/MA/MBA in related field with 3+ year of experience in related field

OR

PhD in relevant discipline

• Demonstrated experience with tissue processing and tissue engineering
• Working knowledge of FDA's Quality System Regulation (QSR) and demonstrate practical application through experience with design controls
• Experience in Mechanical design and Product/Process FMEA
• Demonstrate ability to follow SOPs and defined procedures
• Good computer skills, including proficiency at MS Word, MS Excel and Windows-based operating systems, are ideal; SolidWorks experience/ability to learn is preferred
• Organized, flexible, and able to multi-task while maintaining a high level of efficiency, attention to detail and organization
• Strong oral, written and communication skills
• Must have a professional demeanor and positive attitude
• Must be able to establish and maintain effective working relationships with all members of the research & development laboratories. Must be comfortable interacting at all levels within these functions
• Ability to interact with all levels of management, both internal and external, third party payers, and customers; with a focus on customer service

WORK ENVIRONMENT:

Work to be performed in the Company's Marietta & Kennesaw, Georgia facilities and may include travel to satellite labs or partner/contract research facilities

This position will have contact with biomaterials as well as chemicals used in the manufacture of products

Training will be conducted on the handling and safety practices necessary for the use and disposal of hazardous chemicals and potential biohazards

This position is laboratory based

Possible travel to present at Scientific Conferences and/or meet with collaborators and/or contract research labs several times a year