Works on roadmap for the Vital Care and Specialty business unit. Products from this business unit include human and veterinary patient monitors, veterinary disposables, and temperature management hardware and associated disposables.
Duties and Responsibilites
- Pre-market (NPI/OBL/PFG) and post-market product design
- Requirements definition (e.g. customer requirements, product specifications, system specifications, etc.)
- Customer engagement and interaction
- Vertical/product standards management and subject-matter expertise
- DHF creation and management
- Ability to plan, develop, manage, and track work stream deliverables and detailed design work packages
- Does customer visits and visits trade shows as means of collecting requirements for future device developments
- Devises innovative approaches to complex problems as encountered.
- Is technical leader on 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.
- 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.
- 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 including documentation proceed per requirements of Standard Operating Procedures.
- 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 as well as technical issues.
- 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 devices and development of specific applications at Smiths Medical.
- 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.
- 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.
Required Skills andExperience
- 4yeardegree in engineering or similar 8-12years of experience or 6-8years 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)
- Strong understanding of IEC60601-1 standards
- Strong understanding of design concepts of Disposables
- Working knowledge of: Microsoft Office tools, Visio and MS Project
- Familiarity with systems, electrical and software engineering disciplines
- Proven ability to lead, establish, maintain and influence effective working relationships with internal and external customers across functions.
- High level understanding of the architecture of an electro-mechanical medical device and associated disposables is a plus.
- Driven and high energy that can get things done
- Ability to work with integrity and build trust.
- Advanced problem solving and analytical ability.
- Ability to critically review and interpret technical documentation.
- Ability to work accurately with attention to detail.
- Ability to handle multiple priorities and to meet key deadlines under pressure through effective time management skills
- Ability to clearly convey ideas and concepts verbally and in writing.
- Proven ability to coach and mentor others in technical matters and customer needs.
- Ability and willingness to lead and create change – changes in policy, procedure, technology, and culture.
- Ability to plan and conduct effective meetings and group presentations.
- Strong influencing skills and ability to provide functional supervision to project team members as required
- Strong organizational skills
- Strategic ability with regards to trade-offs in designs and between multiple project needs.