- Research Experience
- Materials Handling
- FDA Regulations
- Quality Systems
Company Overview: LifeSprout is an early stage medical device company developing the next-generation of soft tissue alternatives for aesthetic and reconstructive medicine. The company is led by a management team well-versed in the business, clinical, and scientific aspects of medical device company operation. LifeSprout is seeking an R+D Engineer to support the development of all pipeline programs. LifeSprout's first product; an injectable filler for soft tissue reconstruction, will be regulated as a Class III medical device under the PMA pathway; this will be followed by several products in earlier stages of development.
The R+D Engineer will be responsible for supporting the Research + Development team to draft and establish new assays, protocols and process validation instructions in accordance with LifeSprout's quality system. The engineer will also design and perform research investigations and the development, adjustment, and execution of manufacturing protocols to produce GMP materials. The Process Development Engineer will report to the Head of R&D.
Integral member of the R+D team responsible for supporting activities required to ensure reliability and safety of the design.
Work closely with product development, engineering, operations and regulatory to assure appropriate requirements are defined for the specific device application.
In collaboration with the team, formalize new testing methodologies and approaches required to complete comprehensive analyses of device designs.
Work directly with product development engineering to translate user requirements into design requirements down to the component level, including the identification of critical components and design features.
Experience in performing test methods such as rheology, compression testing, SEM, and/or HPLC.Work with manufacturing to produce composite materials using electrospinning, cryomilling, plasma treatment, wet chemical and other processes.
Conduct validation investigations that confirm reproducibility, scale-up potential, and ongoing quality assurance with manufacturing procedures.
Assist in collaborative research projects with other team members.
Create and refine work instructions and inspection procedures.
Design and conduct research and manufacturing investigations and trend analysis for trouble-shooting development and manufacturing concerns.
Present research findings and data to R&D team for product development.
Undergraduate degree in chemistry, chemical engineering, materials science, biomedical engineering, or a related discipline with 0-4 years of experience in industry.
Experience working and directing collaborative research programs; sharing data and problem-solving collectively on a team.
Demonstrated ability to execute on deliverables and manage milestones.
Previous experience in handling investigations and trend analysis.
Working knowledge of GMP manufacturing processes, FDA and regulatory bodies, and quality systems.
Experience in materials handling and processing; beneficial if previous experience includes electrospinning, hydrogel synthesis, and/or surface modification.
Specific work or academic project experience in the soft tissue aesthetic and/or reconstructive arenas.