GreenMark Biomedical Inc. seeks a Senior Process & Product Engineer in Ann Arbor, MI.
Job duties: Lead the scale-up of novel nanomaterial-based dental products projects from pilot to full-scale manufacturing. Operate and optimize production processes, including lyophilization, nanoparticle washing and solvent exchange, and chemical modification of biopolymers. Ensure batch-to-batch consistency, process validation, and yield optimization using structured methodologies such as Design of Experiments (DOE) and Statistical Process Control (SPC). Develop and manage product-specific quality assurance and quality control (QA/QC) protocols in alignment with FDA Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. Supervise and Mentor junior engineers, laboratory technicians, and interns, fostering a culture of collaboration and technical excellence. Coordinate cross-functional projects with R&D, regulatory, and commercial teams to ensure alignment of objectives. Provide expert technical input to support intellectual property strategies, grant applications, and reporting requirements. Lead analytical testing and characterization of nanomaterials using techniques such as Nanoparticle Tracking Analysis (NTA), Zeta potential measurement, X-ray Diffraction (XRD), and electron and fluorescence microscopy. Support stability and shelf-life studies of materials and finished products. Develop and validate SOPs and acceptance criteria for new analytical methods. Design and maintain Standard Operating Procedures (SOPs), test protocols, and batch records; train and supervise junior staff in quality systems. Collaborate with QA teams to support internal audits, deviation investigations, Corrective and Preventive Actions (CAPAs), and root cause analyses. Design and execute in vitro studies to assess efficacy and biocompatibility for dental remineralization and drug-release applications. Prepare comprehensive scientific reports, technical documentation, grant submissions, presentations, and posters for internal and external stakeholders. Maintain meticulous and compliant records of research procedures, raw data, and test results in accordance with FDA GLP requirements (21 CFR Part 58). Collaborate with regulatory consultants and internal teams to support FDA submissions and other regulatory approvals. Prepare enamel samples and artificial saliva solutions; ensure adherence to biohazard protocols for handling extracted human teeth.
Need Master’s degree in Biomedical Engineering or related. Need 2 years of experience as Bioengineers and Biomedical Engineer, including 2 years of experience in Medical Device QMS, biomaterials characterization, SEM/TEM imaging, Nanoparticle Tracking Analysis, CEM solids analysis, cariology test models, chemical manufacturing for medical devices, scientific communication/data analysis. Limited travel required for conferences or manufacturing activities. Mail resume to 325 E. Grand River Avenue, Suite 314, East Lansing, MI, 48823.
