Smiths Medical is looking for a Manager to lead Product Line Engineering efforts in our Research and Development Department in Southington, CT. This role within our Vascular Access franchise will focus on all aspects of the product lifecycle. The scope of this role includes partnering with Global Product Management to define worldwide product plans, working with functional engineering teams to create detailed designs, and supporting lifecycle activities for existing products.
DUTIES & RESPONSIBILITIES
- Interact with customers, clinicians, and business stakeholders to document clinical/market needs and competitive landscape
- Works on roadmap for the Vascular Access franchise business unit
- Manages requirements definition process for new products (e.g. customer requirements, product specifications, system specifications, etc.)
- Ensure maintenance, safety, efficacy and compliance of existing product lines
- Does customer visits and visits trade shows as means of collecting requirements for future device developments
- Manages all stages of multiple engineering projects. Promotes attainment of organizational objectives through team members including engineers and/or technicians.
- Provides leadership and guidance for non-routine problems requiring substantial judgment in the independent evaluation, selection and adaptation of standard engineering techniques, procedures and criteria.
- Works with vendors and internal departments to obtain necessary resources, resolve inter-departmental issues and contribute toward organizational objectives.
- Provides input to annual budgets for the products they support and is accountable for managing to that budget.
- Manages department resources to assure that all resources are identified and prioritized for tasks.
- Determines team priorities. Resolves conflicts for department resources.
- Reviews the content, thoroughness and quality of the work generated by the team.
- Conduct project/team meetings as required to resolve issues, determine current status, provide information, and assign work. Ensure adequate communication between engineers, technicians, and other departments.
- Maintains open communication with employees to ensure understanding of their needs.
- Provides reports and presentations to management as required.
- Provides written documentation regarding unusual problems and solutions.
- Participates in Engineering Change Order approval process.
- Manages the selection, compensation, appraisal, feedback, training, and development processes within team to ensure optimum attraction, motivation, and retention of employees.
- 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).
- Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or similar with 9-12 years of experience or 5-8 years 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)
- Prior experience working with single use disposable medical devices such as catheters desirable