Performs high level engineering work requiring recognized expertise in this discipline of engineering. Plans and oversees work requiring judgment in the independent evaluation, selection and the substantial adaptation of standard engineering techniques, procedures and criteria. Devises innovative approaches to complex problems as encountered. Leads major projects and provides guidance and direction to engineers and/or technicians for the duration of project. Works with vendors and internal departments to provide technical direction, obtain necessary resources, resolve inter-departmental issues, and contribute toward project and organizational objectives.
Oversees and participates in engineering projects and development activities of significant scope or degree of difficulty. Determines project parameters and assignments for project groups. Works with engineers in various departments to achieve results. Performs projects with only general supervision.
Plans and schedules engineering effort for all assigned projects and monitors progress to schedule.
Performs engineering activities and provides expertise as well as critical review for projects as assigned.
Reviews and guides the resolution of technical issues as needed and ensures that technical work meets requirements and specifications
Creates or contributes to specifications and project plans
Assures engineering activities proceed per requirements of QSSOPs
Maintains frequent communications within and outside of department in support of mechanical engineering activities, such as project management meetings and material review, etc.
Guides the decision-making process; frequently conducts the meeting or presentation, and makes follow-up assignments to team members.
Coordinates communications with vendors to provide technical information and expertise
Participates in and frequently conducts team meetings
Coordinates communications with vendors on technical issues.
Generates or reviews purchase order requests for materials on assigned projects.
Oversees preparation of documentation associated with engineering activities in compliance with company QSSOPs.
Assures appropriate documentation for assigned projects.
Reviews documents from other departments relating to assigned projects.
Develops and conducts Smiths Medical facilitated training and development programs for internal departments or vendors designed to increase knowledge in issues related to functional area of expertise and/or medical device manufacturing and development including GMP, Quality Systems, and specific applications at Smiths Medical
Position Description & Requirements:
Plans and assigns work / project tasks / responsibilities to personnel (typically technicians and engineers assigned to the specific project). Has no direct subordinates; but provides functional supervision to project team members for the duration of project assignment and assists in the evaluation of personnel performance.
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, OHSAS18001 Health and Safety regulations, government occupational health and environmental regulations and statutes).
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Technical Knowledge and Skills:
4 year degree in engineering or similar 10-12 years of experience or 6-9 years with an advanced degree. Applies extensive technical expertise in the engineering field and has full knowledge of other related disciplines (GPM, RAQA, Sales and Ops)
Smiths Medical - 19 months ago
Smiths Medical's forges are primed to produce medical tools for intensive care, surgery, and post-operative care procedures. Part of...