Our Vaccine Client that is funded by the NIH is growing and looking to add an Sr. Engineer, Device Development to their team (sites in Cambridge & Woburn, MA). They are focused on developing next generation vaccines and therapies based on their proprietary technology. This technology enables sustained intradermal delivery of vaccines and therapeutics to enhance efficacy and simplify administration. We are seeking a talented, collaborative, and highly motivated individual to join our core team of scientists and engineers. This is a unique opportunity to be part of an emerging early phase clinical company bringing innovative technology to the global market.
? Work under the VP of Device Development to design device. Focus for this role will be on product design, development, and design for high volume manufacturability.
? Support product development in support of pre-clinical and clinical studies.
? Work closely with the multidisciplinary team and external consultants with specialties spanning Human Factors, Industrial Design, Packaging, Manufacturing, Engineering, Biocompatibility, Quality, and Regulatory.
? Lead the selection and management of outside vendors.
? Generate all required documents to support device related components of design control requirements (21 CFR 820, ISO 13485 ISO 14971) and regulatory requirements for combination products (21 CFR Part 4).
? Develop test methods, generate and maintain design specification, write protocols & reports, lead prototype generation, design verifications & validations, conduct FMEA’s, etc. in line with ISO 14971 Risk Management.
? Conduct activities within a quality management system following 21CFR820 Quality System Regulation.
? Mentor junior team members in the drug-device combination process.
? BS in Mechanical or Biomedical Engineering, with at least 7 years of direct experience leading the development of medical devices, ideally drug-device combination products.
? Understanding of material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
? Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required.
? Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
? Collaborative problem solving, risk assessment, and risk management skills.