Engineer III

Smiths Medical

(Gary, Indiana)
Full Time
Job Posting Details
About Smiths Medical
At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets.
Responsibilities
* Performs engineering work requireing full competency in all conventional aspects of engineering. * Plans and conducts work requiring judgement in the independent evaluation, selection and the substantial adaptation of standard engineering techniques, procedures and criteria; devises new approaches to problems as encountered. * Plans and coordinates detailed phases of the engineering activities for part of a major project or a total project of moderate scope. * Conducts engineering activities of significant scope or degree of difficult (medium-large component/system/processes associated with a medium to 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/capatiliby 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. * 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 knowledge of all standards, government occupational health and environmental regulations and statutes related to the site). * Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Ideal Candidate
**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. * Masters degree in Engineering, with 4-6 years engineering experience also meets requirements. * PhD in Engineering, with 3-5 years engineering experience also meets requirements * Possesses and applies a comprehensive knowledge of engineering, as well as competency in related specialty fields. Knowledge is evidenced by a cumulative GPA of 3.0, or above in engineering major, plus breadth of experience, pevious job progression, accomplishments and performance levels. * 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. **Abilities:** * Ability to coordinate and lead project team activities in an effective and efficient mannger. Team members typically include diverse inter-department staff including Regulatory, Marketing, Purchasing, Operations, Design, QA, Production, etc., requiring a significant amount of organizational and motivational skill. * Ability to work with vendors to ensure quality products. * Ability to handle and work under stressful situations. * Excellent verbal communication skills and technical writing skills. Able to plan and conduct effective meetings and group presentations.

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