R&D Engineer Advanced Operations

Overview

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities.

Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles.

The R&D Engineer will drive the scale-up and transfer of new processes developed within R&D to Manufacturing, including process design, development, and verification. This position is focused on manufacturing systems and procedures required for the manufacture and scale-up of new tissue products. The Engineer serves as the voice of Operations in the Product Development process. Knows and applies engineering fundamentals through creative problem solving; design and fabrication of prototypes, evaluation of new concepts, solid modeling and drafting, participation in brainstorming and other team activities, and coordination of mechanical, physical, chemical and biological testing as required. The Engineer may also participate in process design for manufacture of clinical-grade tissue forms at any stage of product development so that novel tissue forms may be manufactured and released for pilot clinical evaluation.

Salary: $93,348

This role requires you to be on site. Must be commutable to Edison, NJ 

Responsibilities

• Lead the scale-up and transfer of processes associated with new tissue form(s) developed by R&D to be integrated in Operations.
• Participates in developing the integrated cross functional plan for scale up and transfer including financial cost of goods, capacity analysis, workflow, yield analysis, job safety analysis, capital equipment, facilities, processing toolkit and equipment design, packaging and sterilization processes, quality control methods, material (raw materials and finished goods) storage and control, and IT system needs.
• Participate in development, completion, application, and compliance of procedures associated with product transfers and launches.
• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with MTF procedures.
• Design processes to manufacture clinical-grade tissue forms for pilot clinical evaluations that are in compliance with MTF procedures.
• Will assist in the selection of materials, components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Summarizes test data, makes observations and recommendations, and write and release engineering documents (reports, procedures, forms, flow charts, etc.).
• Maintain records to document novel design and process development activities for Intellectual Property development.
• Provides on-going status reports including periodic reviews progress and evaluation of results to management.
• Ability to gown and enter clean room to develop processes and provide hands on training for manufacturing team members on new products, tooling, equipment and process revision.
• Ensure adherence to GTP, relevant industry processing standards and guidelines and safety procedures.
• Assist on special projects and perform additional duties as assigned. Assignments are broad in nature, requiring originality and ingenuity.

Qualifications

• Bachelor's Degree in Engineering (e.g. Mechanical, Chemical, Materials Science, Biomedical)
• Minimum of 4 years’ experience in engineering of implantable surgical devices or tissues.
• 2-5 years’ experience in a regulated industry
• Experience with transferring product(s) and/or process(es) from R&D to Operations / Manufacturing.
• Basic knowledge of tissue (human, animal) manufacturing processes, materials, product and processdesign
• Self- starter with demonstrated efficient work methods, analytical & problem solving skills andability to handle multiple tasks in a fast paced environment.
• Proficiency to create, read, and interpret CAD including 3-D solid modeling is preferred.
• High level of PC Skills required.
• The individual should enjoy working in a fast paced, dynamic and results orientated team environment
• Knowledge of manufacturing practices in a clean room environment.
• Strong communication skills with the ability to effectively work cross-functionally and externallyas required.
• Must be able to read and interpret complex engineering documents and have the ability to understandprocessing and operating procedures
• Excellent attention to detail.
• Experience collaborating with key internal functions and groups; i.e. R&D, Operations, Process
• Engineering, Quality Engineering, Supplier Quality, Regulatory.
• Experience collaborating with external vendors and suppliers.
• Excellent written and verbal communication skills.
• Ability to present information to a variety of audiences.

Benefits Information

At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.

• 4 weeks Paid Time Off (PTO)
• Paid Holidays
• Medical, Dental,  Vision Insurance and Prescription Drug Insurance
• 401K plan with company match
• Short & Long Term Disability
• Life & Accidental Death Insurance
• Tuition Reimbursement
• Health Care/Dependent Care Flexible Spending Accounts
• Adoption Assistance
• Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
• Sword Health (at home Physical Therapy)