Project Manager, Manufacturing Engineer, Quality Engineering

Project Manager

Work Schedule:

" Monday Friday Days

Environmental Conditions:
" Office environment with extended periods in seated position
" Manufacturing environment including some areas with elevated noise levels
" Manufacturing environment including controlled and uncontrolled cleanroom areas
" PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.) as required by area
" Adherence to all GMP (Good Manufacturing Practices) and safety standards required

Role impact
This role is part of the capital engineering team to provide new manufacturing equipment that supports Client Scientific FSD (Filtration and Separation Division) manufacturing sites. It will be responsible for ensuring the quality, safety, and performance in the execution of capital projects including the specification, design, build, and installation of manufacturing equipment.
This role will have direct responsibility for new manufacturing equipment projects as well as projects to improve productivity, capacity, cost reduction, and efficiency of existing equipment. It will be responsible for ensuring the highest levels of workmanship and professionalism.

Role Requirements
Education
" Technical/Engineering Bachelor s degree with 5 years (or Master s degree with 3 years) of demonstrated applicable experience.
Experience
" Managing capital projects for manufacturing equipment (manual and automated)
" Leading technical efforts of equipment design and development projects
" Using critical metrics for measuring and improving personal work performance
" Managing personal individual effort across multiple concurrent projects
" Managing vendor design, build, and install efforts to ensure overall project success
" Implementing engineering tools and methods for tasks such as experimentation (DOE), risk assessment (FMEA), process control (SPC), and statistical analysis
" Managing projects to applicable international standards (e.g. ISO, CE, FDA, etc.) desired
Knowledge, Skills, Abilities
" Proficient in MS Office and Solid Works/PDM (or equivalent)
" Proficient in technical writing including authoring engineering protocols, reports, and procedures
" Medical Device/Biopharmaceutical manufacturing (i.e. GMP, FDA, ISO 13485) experience desired
" Self-motivated with good problem solving, communication, and coordination skills
" Self-starter with demonstrated history of continuous improvement and drive for results