Sr Product Development Engineer

Tela Bio Inc•Malvern, PA

17h•Onsite

About The Position

This 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.

Requirements

Bachelor’s Degree in Engineering (e.g. Biomedical, Materials, Mechanical)
5+ years’ experience in medical device product development including all phases of the product development lifecycle
Strong technical writing experience
Exposure 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 development
Strong organizational and project management skills
Strong analytical skills with demonstrated experience with organizing, managing, and presenting data to management
Ability to be self-directed given departmental goals

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 documentation
Design 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 needed
Conduct and/or oversee performance testing to assist research programs and development projects
Manage and conduct the translation of customer needs into product requirements and design specifications.
Support regulatory submissions and technical file creation
Plan and rapidly manage/implement new product transition activities between proof-of-concept and manufacturing
Participate in early-stage development, prototyping, and test activities
Liaise with Quality and Technical Operations groups in validation and launch of new products