LifeSprout Senior Process Engineer in Baltimore, Maryland
Founded in September 2015 as a spinout from Johns Hopkins University, LifeSprout is a 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?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 Process Development Engineer will be responsible for implementing and improving manufacturing processes to produce composite materials by improving reliability, upscaling production, and reducing costs. The engineer will draft and establish new process validation instructions in accordance with LifeSprout?s quality system. The engineer will also design and perform research investigations into novel products and processes and the development, adjustment, and execution of manufacturing protocols to produce composite materials. The Process Development Engineer will report to the Director of Operations.
Support the development of improved processes of manufacturing composite materials using electrospinning, cryomilling, plasma treatment, and chemical processes, as well as other mixing and filling and packaging operations.
Conduct process validation investigations (IQ/OQ/PQ) that confirm reproducibility, scale-up potential, and ongoing quality assurance with manufacturing procedures.
Support the development of a continuous improvement and lean manufacturing environment.
Work with key contract manufacturers to refine processes and assure delivery of key products and components.
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.
Assess and mitigate safety hazards associated with the manufacturing processes.
Undergraduate degree in mechanical or biomedical engineering, or a related discipline with 3+ years of experience in industry
Experience in materials handling and processing; beneficial if previous experience includes electrospinning, hydrogel synthesis, and/or surface modification.
Experience working and directing collaborative programs with other engineers; sharing data and problem-solving collectively on a team.
Experience working with outside suppliers.
Demonstrated ability to execute on deliverables and manage milestones.
Previous experience creating work instructions and inspection procedures/processes.
Previous experience in handling complaint investigations, trend analysis, and/or CAPA analysis.
Exposure to lean manufacturing, six sigma and/or other process improvement principles.
Working knowledge of GMP manufacturing processes, FDA and regulatory bodies, and quality systems.
Eligibility to work in the U.S. is required
Graduate degree in mechanical or biomedical engineering, or a related discipline
Six sigma green belt or higher.
Specific work or academic project experience in the soft tissue aesthetic and/or reconstructive arenas.