SUMMARYPerforms high level design engineering work requiring recognized expertise in all aspects of mechanical design engineering in Vascular and potentially non Vascular related products. 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.
ESSENTIAL DUTIES ANDRESPONSIBILITIES
- Oversees and participates in mechanical engineering design 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.
- 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.
- Develops and conducts 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.
MINIMUM EDUCATION ANDEXPERIENCE
Bachelor's degree in Mechanical Engineering, or closely related engineering field, with at least ten years’ professional level experience in mechanical engineering within the medical, or a closely related industry is required. Or Masters degree in Mechanical Engineering, or related engineering field, with seven to ten years medical, or closely related experience also meets requirements. Or Ph.D. in Mechanical Engineering, or related engineering field, with six or more years medical, or closely related experience also meets requirements. Cumulative GPA of 3.0, or above, in engineering major is required
MINIMUM KNOWLEDGE, ABILITIES AND SKILLS
- Possesses and applies a recognized expertise related to mechanical design engineering specialization, as well as competency in related specialty fields.
- Depth of knowledge of SOPs, GMP/FDA/ISO9, etc., principles and proven skill in integrating into mechanical design engineering discipline.
- Ability to manage projects of significant scope and impact. Uses considerable judgment in the planning, scheduling and coordinating of project phases and resources, as well as the selection of engineering techniques and criteria. Strong analytical and problem solving skills are required. Ability to lead and guide project team members in troubleshooting and carrying out major project phases.
- Verbal communication skills and technical writing skills. Able to plan and conduct effective meetings and group presentations. Ability to provide technical presentations to internal departments and outside of the organization.
- Ability to coordinate and lead project team activities in an effective and efficient manner. Team members typically include diverse inter-department staff including Regulatory, Marketing, Purchasing, Operations, Design, QA, etc., requiring a significant amount of organizational and motivational skill.