Description

Position Title: Senior Product Development Engineer (Onsite - based in Malvern PA) Position OverviewThis position will be a key member of the Product Development team and will participate in the design, testing, quality control, and ultimate manufacture of TELA Bio surgical reconstruction products.  This position will be also critical in the transfer of technology and subsequent iterations to manufacturing.  The individual will be required to work in a regulated environment and will be able to complete GxP documentation requirements.Essential Duties and Responsibilities Author development documentation consistent with design control requirements such as product specifications, verification/validations studies, etc.Lead the generation of risk management file and usability engineering file documentationDesign and document testing and experimental work in accordance with GxP.Coordinate with outside labs, suppliers, regulatory bodies supporting product development, product testing and process development, as neededConduct and/or oversee performance testing to assist research programs and development projectsManage and conduct the translation of customer needs into product requirements and design specifications.Support regulatory submissions and technical file creationPlan and rapidly manage/implement new product transition activities between proof-of-concept and manufacturingParticipate in early-stage development, prototyping, and test activitiesLiaise with Quality and Technical Operations groups in validation and launch of new products Education and ExperienceBachelor's Degree in Engineering (e.g. Biomedical, Materials, Mechanical)Required Knowledge, Skills and Abilities 5+ years' experience in medical device product development including all phases of the product development lifecycle Strong technical writing experienceExposure to statistical analysis, biocompatibility testing, sterilization validation, shelf-life and packaging/ sterile barrier system validation Demonstrated ability to multi-task and to function in a fast-paced start-up environment, manage time efficiently, achieve goals with minimal supervision and effectively interact with other employees, departments, service providers and development partners.  Excellent work-ethic and attention to detail Demonstrated ability to think creatively to identify unique solutions for product developmentStrong organizational and project management skillsStrong analytical skills with demonstrated experience with organizing, managing, and presenting data to managementAbility to be self-directed given departmental goals Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to:Ability to carry and lift product inventory of up to 20 lbs.Must have demonstrated ability to multitask in high pressure, changing conditions. Working ConditionsThis position works in the corporate office.  The noise level in the work environment is quiet to moderate.   Primary Location and TravelWe anticipate that on an ongoing basis this role will be based in the Corporate Office with the ability to work from home one day a week after initial training is completed. No travel is expected for this position. DisclaimersThis is a representative description of the job and is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice. TELA Bio, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law. For more information, please check out our website: www.telabio.com

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