Support projects for the development of biological tissues, products and devices, packaging and processes within the MTF Design Control System for Orthopedics, Plastic and Reconstructive Surgery, Wound Care or other applications. Provide technical support for process, product and/or packaging activities and characterization studies. Participate in design and execution of experiments, prepare technical reports for review with interdepartmental project teams and project managers.
Contribute to formulation, development, scale-up, and transfer of new tissue forms/product and packaging design, prototyping and testing. Conduct product and/or packaging stability studies. Design mechanical, physical, chemical or biological test methods and test protocols to characterize properties of tissue and/or packaging; perform tests and record information; provide reports required to meet Design Control requirements. Prepare and test samples for safety, design verification and validation testing and preclinical characterization. This may include physical and mechanical testing of tissue, biocompatibility testing, chemical analysis, packaging testing, biological cell/tissue cultures and biochemical studies. In addition, prepare tissue/product/packaging prototypes for feasibility testing or evaluations by Marketing or customers. Conduct data analysis; generate statistical summaries and reports from collected data along with submission of Lab Experiment reports that are approved in the corporate documentation management system. Support drafting standard operating procedures and work instructions. Perform record keeping for all experiments and research activities in compliance with GLP and MTF design control procedures. Support and execute Design of Experiment (DOE) activates to establish product or process specifications. Coordinate and monitor external studies, summarize activities and test results and prepare final report. Prepare samples and documents for biocompatibility and animal studies. Prepare prototypes for handling and cadaver labs on or off-site associated with gaining customer input. Prepare and present project results and updates to project teams and R&D management. Train R&D, Engineering or Processing team members, including new hires on SOPs and protocols in general laboratory practices, aseptic techniques, test methods, assay procedures or preparation/processing of tissue and/or packaging studies. Supervise co-ops and interns as they perform experimental studies. Perform laboratory duties to maintain safety and operations of laboratories. Assist onsite to monitor studies at contract or university laboratories and attend scientific conferences and seminars to keep up-to-date on novel and related technology. Participate in patent review of prior art. Assist on special projects and perform additional activities as assigned. MINIMUM QUALIFICATIONS Education: Bachelor's Degree
Other: in Engineering discipline (e.g. Mechanical, Biomedical, Chemical, Materials Science, Tissue Engineering)
Years of Experience: Other
Other: 1 years experience.
Specialized Knowledge, Technical Skills, and Abilities:
Proficiency in Microsoft Word and Excel, and basic statistical analysis
Strong organizational, written and verbal communication skills
Ability to work within a multifunctional team environment
Working knowledge of Good Laboratory Practices (GLP)
Knowledge of biomaterial or device evaluation
Experience in biological and biochemical techniques such as cell/tissue culture, development of
biochemical assays, to support in vitro, in vivo and/or mechanical testing
Working knowledge of aseptic technique
Must be familiar with all basic laboratory equipment (sterile hoods, balances, mixers, pipettes, etc
