OPPORTUNITIES : CAREERS @ TEPHA Tepha has established itself in the field of tissue engineering, and we are currently expanding into other therapeutic areas with our core technology.  We pride ourselves on leadership and innovation, hence fostering an organizational structure that allows employees freedom to grow. Tepha offers successful candidates an environment of market leadership, product innovation and personal growth.  To join us in an exciting future, browse the current opportunities below and submit your resume through the applicable links. Extrusion Engineer Quality Engineer Extrusion Technician Equipment Development Engineer Extrusion Engineer Manager of R&D Polymer Extrusion Engineer Biomaterials Researcher   Extrusion Engineer Job Description and Duties Perform development and commercialization of novel new biopolymer medical products. Develop manufacturing processes and scale-ups into commercialization. Develop equipment through proof of concept and implementation in manufacturing. Responsible for the assembly, maintenance, set up and operation of extrusion equipment. Develop processes to produce monofilament / multifilament for use in medical devices. Develop medical textile processes and preparation of samples for various studies. Responsible for testing including rheometry, melt flow indexing, tensile and fatigue. Analyze test data and reports to determine conformance to requirement. Write and execute test procedures and SOP’s. Research, develop, and evaluate materials, processes and/or equipment. Conduct feasibility studies to verify capability and functionality. Participate in quality reviews, E, I, O & P Q’s. Maintain safe work environment and adherence to Quality System Regulation (QSR). . Qualifications Requirements include a Master’s degree or equivalent in engineering or chemistry and 5 years of pre- or post-degree work experience in the job offered or related field of fiber extrusion development. . Skills/Knowledge/Experience Thorough knowledge of fiber extrusion and biopolymer rheology and process analysis; Extrusion in theory and practice; Mathematical modeling techniques and statistics; Word, Excel and MS Project; Validation and design control. Experience with various types of extrusion equipment, hardware and control systems; Ability to work on problems that are diverse in scope, where analysis of data requires evaluation of identifiable factors; Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions; Statistical design of experiments, process flow diagrams, device design controls, process simulation and engineering software. Applicants must have unrestricted authorization to work in the United States. Position Type:   Full-time Shift:   Days Salary:   $78,624.00 Reports to:   Vice President of Operations Please forward resume to:        Vice President of Operations        Tepha, Inc.        840 Memorial Drive        Cambridge, MA 02139 (Post Date: October 14, 2005) Apply for this position.   Quality Engineer Job Purpose This position requires a qualified candidate who is able to work effectively in a fast paced, exciting environment that embraces change and flexibility. In this position the candidate must be able to communicate effectively with other cross-functional team members while providing quality engineering and compliance leadership on a daily basis to support the growth of the company. Duties Review and/or create policies, procedures and work instructions relating to the quality system Develop process validation protocols and reports and oversee their execution Lead and/or participate in risk management activities, e.g. Design and Process FMEA Participate on new product development teams and ensure compliance with design control requirements May conduct internal and vendor audits (depending on experience and prior training) Qualifications A minimum of 2 years quality engineering experience in the medical device industry and a 4 yr degree in a technical discipline. ASQ certification as a CQE is highly desirable. Skills/Knowledge/Experience Knowledge and good comprehension of FDA’s Quality System Regulation (QSR, a.k.a. Good Manufacturing Practices or GMP) and ISO 13485. Experience with process controls and validation activities Quality control inspectional skills Good documentation skills Strong PC skills (database development skills a plus) Knowledge of statistical sampling and analysis Design control experience a plus Auditing skills a strong plus Additional Qualifications Motivated self-starter with ability to work with minimal supervision Excellent written and verbal communication skills Detail oriented and well organized Ability to multitask and work in fast paced environment Good interpersonal skills Position Type:   Full-time Shift:   Days Reports to:   Director of Quality Systems Apply for this position.   Extrusion Technician Responsibilities Operate fiber extrusion and downstream equipment. Assemble, disassemble, clean and inspect various components. Maintain records and data log sheets. Aid in process optimization to improve quality, yields, make recommendations, involving equipment modification, spare parts inventory and preventive maintenance procedures. Test material in accordance with ASTM and USP standards including recording of data and results. Requirements Excellent Microsoft Office skills Candidate must have 3-5 years minimum experience in the assembly, set up and operation of extrusion equipment. Medical device work experience is a plus. Apply for this position.   Equipment Development Engineer Responsibilities You will be responsible for the design and implementation of new equipment used in research and production. Design project include fermentation and extrusion systems, textile equipment, pneumatic, thermal and mechanical systems. Responsible for calibration of instruments, downstream equipment, establishing specifications, validation documents, installation and training. Qualifications BS/MS mechanical or electrical engineering with 5-10 years of experience in medical device environment is required. Apply for this position.   Extrusion Engineer Responsibilities You will be responsible for the assembly, set up and operation of existing extrusion equipment, as well as the development of processes to produce monofilament / multifilament for use in medical devices. You will be responsible for testing performed including rheometry, melt flow indexing, tensile and fatigue. Analyze test data and reports to determine conformance with requirement. You will write, and execute test procedures and process specifications. Requirements Basic mathematical modeling techniques and an understanding of statistics including design of experiments are important. Knowledge of statistic process control, six sigma, and other design for excellence methods will be a benefit. Good understanding of extrusion in theory and practice is a must. Team player motivated by success of the company, goal oriented, excellent communication skills, both written and oral. BS/MS in chemical or mechanical engineering with 5+ years minimum experience in the development and trouble shooting of extrusion processes with knowledge of validation and design control. Apply for this position.   Manager of R&D Job Purpose You will lead transfer of processes from development to clinical manufacturing scale for new combination device/drug products. New products may include implantable devices, erodible polymers for injection, and transdermal technologies. Management of a group of 2-4 process engineers will be involved, with the goal of conducting studies to characterize a process using pilot scale equipment and develop a robust, reproducible, manufacturing process. Management of process engineering activities for a larger project are important to this position in order to achieve the targeted results on time and on budget. Qualifications Written communication in the form of technical reports, notebooks, INDS, NDA CMC sections, and technical highlights is an important job responsibility that will require timely execution. BS/MS in chemical engineering, bio-engineering or equivalent and 10+ years experience in process industry. Must have good communication and interactions skills for working with many other departments. Good people skills are important to this position. You will be responsible for coaching direct reports, helping them develop their careers, and holding them accountable for results. Frequent reporting to management will be required. Skills in statistical design of experiments, process flow diagrams, device design controls, process simulation and other engineering software, etc. are preferred. High level of skill in Word, Excel and MS Project required. Apply for this position.   Polymer Extrusion Engineer Job Purpose: Polymer extrusion, support in process development, and maintenance of equipment for Tepha biomaterials research projects. Description: The ideal candidate for will be "hands-on" type working on the extrusion of Tepha biopolymers. This position will require skills necessary for plastics extrusion including machinery and control systems. The polymer extrusion engineer should have a solid background in different types of extruders, extruder hardware, important polymer properties as well as functional process analysis. The successful candidate will ensure the best practices in manufacturing. Specific Duties: Provide mechanical engineering support in the creation and the development of new (invasive) medical device products. Research, develop, and evaluate materials, processes and/or equipment. Conduct feasibility studies to verify capability and functionality. Develop new concepts from initial design to market release. Qualifications: Bachelor's degree in mechanical engineering, manufacturing engineering or related major with a background in material science. Ability to work on problems that are diverse in scope, where analysis of data requires evaluation of identifiable factors. Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact. Ability to interface with doctors, chemists, and lab personnel. Experience with polymer extrusion process required. R&D experience with sutures, staples, meshes, and stents preferred Apply for this position.   Biomaterials Researcher Purpose: Development, support execution, and implementation of Tepha’s biomaterials research projects. Description: A researcher is involved in many aspects of producing and developing Tepha's biomaterials. This position will require skills necessary for the production, isolation and purification of biomaterials. This will include basic skills in wet chemistry, such as extraction, filtration and precipitation. Additionally, a researcher will need to use appropriate analytical tools to characterize and qualify the biomaterials, such as gas chromatography, thermal analysis and size exclusion chromatography. The nature of Tepha, Inc. business dictates that personnel must remain flexible with the ability to accept responsibilities within their educational and training levels. Duties: Investigate feasibility, applying scientific principles and concepts to potential technologies, materials, processes and products. Plan and execute laboratory research to prove feasibility of concepts. Produce, isolate, purify, characterize and process materials. Qualifications: Relevant degree in physical science such as chemistry, physics, materials science or biology. Knowledge on cardiovascular physiology, anatomy and cardiac rhythm management devices preferred. Experience with leads or implantable device development preferred. Apply for this position.