Staff Engineer

Summary of the position Responsible for creating and implementing technical pathways for the development of new tissue forms and accessory platforms and their derivatives designed to meet specific surgical and anatomic functional requirements for orthopedic applications, particularly in the field of Sports Medicine.  Major elements of position:  Supervise engineers, designers and technicians to develop new allograft tissue forms and accessory products including instrumentation and delivery systems.   Work closely with the marketing function to establish product design criteria; utilize technical resources to carry out product development tasks and development of process techniques for transition to manufacturing.  Provide technical support to marketing and sales during product launch.   Manage major platform projects within the company and with academic, commercial, and strategic partners on collaborative efforts including establishment and coordination of test protocols in a laboratory, animal, or human clinical setting.   Develop experimental protocols and test methods associated with all aspects of product development.  Collect appropriate data and provide analysis with conclusions and recommendations for further action.   Provide routine progress reports and presentations to management and senior management.   Create intellectual property.   Prepare and manage department budget.   Attend scientific meetings and conferences, review relevant journal articles and investigate new technologies suitable for use by the company in the creation and development of new tissue forms and accessory products.   Provide project management leadership as required including development of the technical plan.   Job Qualifications (education, experience, knowledge, skills and physical requirements): 1. Bachelors or advanced degree in Mechanical Engineering, Biomedical Engineering, or related field.   Minimum of ten (10) year’s experience in design/development and process engineering of implantable surgical devices for orthopedic applications.  Experience must include established examples of design and development work leading to the introduction of an implantable medical device and its accessories (instrumentation and/or delivery mechanism).   Supervision of engineers and technical staff to achieve technical developmental goals and timelines.   Track record of collaboration with surgeons and medical specialists and scientists to assess new ideas and to initiate prototyping and prototype testing in laboratory, animal laboratory, cadaver lab, or clinical setting.   Highly motivated with strong analytical problem-solving skills and the ability to work independently on multiple projects concurrently.   Established knowledge base in biomechanical analysis and materials properties including biologic tissue forms, metals and polymers. Must include experience using mechanical test equipment (MTS or Instron) and various standardized tests used to characterize mechanical properties along with data analysis utilizing statistical methods   Experience with CAD design and equipment and tooling used to machine and fabricate orthopedic devices.   Experience working with internal and external design and fabrication resources to provide direction in utilization of those resources to achieve development timeline and budge objectives.   Significant knowledge of medical device product development processes, regulatory requirements including Design Control, Device History Files, Device Master Record, and Risk Analysis.   Experience in developing and annual plan and budget against project goals.   Excellent written and verbal communication skills. Ability to present information to a variety of audiences.   Practical experience with patent review and development.   Project management experience across multifunctional team environment.   Ability to travel approximately 20%. MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: Edison, NJ 08817 JOB CATEGORY: Engineering TYPE: Full Time, Employee COMPANY: MRINetwork CONTACT NAME: Annette Nocera EMAIL: Apply by Email