Performs high level systems engineering work requiring recognized expertise in all aspects of engineering in order to document requirements and test that those requirements are being met.
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.
Works with outside vendors and internal departments to provide technical direction, obtain necessary resources, resolve inter-departmental issues, and contribute toward project and organizational objectives.
Duties include the technical management of activities in and out of Smiths Medical, in a fast paced global environment, for product development from concept, design and into production.
Oversees and participates in engineering design and development activities of significant scope or degree of difficulty.
Determines project parameters and assignments for project groups.
Works with cross functional engineers to achieve results.
Performs projects with only general supervision.
Plans and schedules effort for all assigned projects and monitors progress to schedule.
May oversee testing for assigned projects.
Performs systems 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 design specifications, project plans, requirements traceability, standards mapping and assurance cases.
Assures design activities proceed per requirements.
For certain assigned projects, may be required to assure that all requirements are properly documented and test verification is completed as assigned.
Lead or assist with saleable product definition and structure, and product numbering.
Assist in identification and evaluation of tools and technologies for improving product development practice.
Maintains frequent communications within and outside of department in support of 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 as assigned.
Oversees preparation of documentation associated with design engineering activities in compliance with company QSSOPs.
May create and/or review design verification test protocols and reports, design of experiments, usability testing and hazard analysis.
Assures appropriate design documentation for assigned projects.
Generates and/or reviews component documentation as assigned.
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 to personnel (2-4 individuals who are either technicians or engineers assigned to the specific project) for project tasks and responsibilities; assists in the evaluation of personnel performance.
Has no direct subordinates; provides functional supervision to project team members for the duration of project assignment.
Write usability engineering plans and reports as assigned.
Identifies and communicates relevant systems related standards and regulatory guidelines
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:
University degree in Engineering, or closely related engineering field, with at least ten years’ professional level experience in engineering within the medical, or a closely related industry is required.
Masters degree in Engineering, or related engineering field, with seven to ten years medical, or closely related experience also meets requirements.
Ph.D. in 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
Possesses and applies a recognized expertise related to engineering specialization, 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, previous job progression, accomplishments, project management skills, and performance levels.
Knowledge and skill in engineering documentation procedures, development methods and project management, with the ability to rapidly master Smiths Medical MD, Inc. 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 engineering discipline.
Smiths Medical - 14 months ago
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