Performs engineering work requiring full competency in all conventional aspects of engineering. Plans and conducts work requiring judgment in the independent evaluation, selection and the substantial adaption of standard engineering techniques, procedures and requirements. Plans and coordinates detailed phases of engineering actions for part of a project.
Conducts engineering activities of significant scope or degree of difficulty. This could include medium – large components/system, processes associated with a medium or large project.
Performs most assignments independently with only general supervision / instruction as to expected results.
Oversees mechanical design testing for assigned projects.
Performs design and provides expertise as well as critical review for projects as assigned.
Reviews and guides the resolution of technical issues as needed and assures that technical work meets requirements
Contributes to design specifications and project plans.
Assures design activities proceed per requirements of company SOPs.
Maintains communications within and outside of department in support of engineering activities, such as project management meetings, material review, etc. Actively participates in and contributes to the decision-making process; often conducts the meeting or presentation, and makes follow-up assignments for team members.
Attends 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 to include drawings/schematics, validation/capability testing, various new and revised operating procedures, etc.
Creates and/or reviews design verification test protocols and reports, design of experiments and hazardous analyses.
Assures appropriate design documentation for assigned projects.
Generates and/or reviews component documentation.
Reviews documentation from other departments such as Quality Assurance, Purchasing, Regulatory Affairs, etc.
Position Description & Requirements:
Routinely provides guidance and direction to engineers and/or technicians for the duration of a project assignment.
Participates in and conducts Smiths Medical facilitated training and development programs designed to increase knowledge in issues related to medical device manufacturing and development, such as GMP, Total Quality, etc., as well as their application.
Plans and assigns personnel (2-4 individuals who are either technicians or engineers assigned to the specific project) to project tasks and responsibilities; assists in the evaluation of personnel performance. Generally, has no direct subordinates; provides functional supervision to project team members for the duration of a project assignment.
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:
Scientific University Degree (BS degree) required
University degree in Engineering or related engineering field, with 7-10 years professional level engineering experience. Medical industry experience is preferred
Uses considerable judgement in the planning, scheduling and coordinating of project phases, as well as the selection of engineering techniques and criteria. Strong analytical and problem solving skills are required.
Knowledge and skill in engineering documentation procedures, development methods and project management, with the ability to rapidly master Smiths Medical internal procedures and methods, such as Documentation System, ECOs, DOEs, DVTs, MDAs, etc.
Depth of knowledge of SOPs, GMP/FDA/ISO 9000, etc., principles and proven skill in integrating into mechanical engineering discipline preferred.
Smiths Medical - 18 months ago
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