Manufacturing Process Engineer
Smiths Medical is a leading global provider of medical devices for the hospital, emergency, home and specialist environments. Our products are used during critical and intensive care, surgery, post-operative care during recovery, and in a series of high-end home infusion therapies.
We offer 12 of the most respected and easily recognisable within our portfolio: Portex™, Medex™, Deltec™, Level1™, Cozmore™, Pneupac™, Wallace™, CADD™, BCI™, Jelco™, Medfusion™ and Surgivet™.
Job Purpose:
Perform complex manufacturing and quality engineering work and provide technical expertise and critical review on projects of significant scope or degree of difficulty. Plan, assign and evaluate the work of lower lever engineers, technicians and operators. Participate in recruiting and selection for the department to ensure qualified engineers, technicians and operators are in place to support manufacturing engineering projects. Provide leadership and guidance for non-routine problems requiring judgment in the independent evaluation, selection and adaptation of standard design engineering techniques, procedures and criteria. Determine project parameters and assignments for project teams and technicians to ensure effective utilization of resources. Collaborate with Business Unit Manager and project team members to define project scope, project plan and specifications.
The position supervises and leads Technicians and Junior Engineering staff towards meeting assigned goals and objectives in the areas of safety/EHS, quality and regulatory, cost, delivery, inventory, and overall line performance. The position has “dotted-line" responsibility for the staff and products of the assigned line(s). In coordination with other Engineers and leaders within the organizations executes those strategies outlined and agreed upon for franchise growth.
Requirements:
Perform manufacturing and quality engineering activities of significant scope or degree of difficulty, including authoring of detailed project schedules; identify activities and sub projects, estimating work duration, and skills need. Perform assignments independently with minimal direction as to expected results.
Lead and perform manufacturing engineering work. Prepare documentation to project level specifications to ensure that required supporting documentation exists (i.e. drawings, validations, procedures, etc.). Assess product/assembly costs and identify optimizations.
Perform significant root cause analysis on problem investigations.
Provide expertise as well as critical review for projects as assigned.
Contribute to and write project plans as directed by management, to include resource availability considering other departments for deliverables or those impacted as stakeholders and cost estimates.
Primary interface with key suppliers, contract and internal production areas.
Oversees daily line operations, participating in the supervision, review, development, and discipline of hourly staff. Has overall responsibility for line performance as measured by safety/EHS effectiveness, quality, regulatory compliance, cost, inventory, and continuous improvement activities.
Participates in the development and execution of daily, weekly, and monthly production schedules to meet business needs as well as departmental objectives
Communicates regularly with assigned team regarding line, site, division, and company performance.
Maintains communications within and outside of the Business Unit regarding of line activity and performance.
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, six sigma, lean, etc., as well their application at Smiths Medical ASD
Technical Knowledge and Skills:
- Bachelor’s degree in engineering discipline with seven to ten years' professional level experience with the medical, or a closely related industry. Two years supervisory/project leadership experience is also required.
- Master’s degree in engineering discipline, with five to seven years product design and development experience within a medical or closely related industry. Two years supervisory/project leadership experience is also required.
- Ph.D. in engineering discipline, with five or more years' product design and development experience within a medical or closely related industry. Two years supervisory/project leadership experience is also required.
- Possess and demonstrate a recognized expertise related to an engineering discipline as well as competency in related specialty fields. Knowledge is evidenced by an engineering degree plus breadth of experience, previous job progression, accomplishments, project management skills, and performance levels.
- Working knowledge and skill in engineering documentation procedures, development methods and project management, with the ability to rapidly master Smiths Medical ASD internal procedures and methods, such as Documentation System, ECOs, DOEs, DVTs, etc.
- Depth of knowledge of SOPs, GMP/FDA/ISO 9000 principles and regulations. Proven skill in integrating these requirements into engineering projects.
- Knowledge of statistical and quality tools (SPC, Confidence Level sampling, Process Capability Indeces) and how to apply them.
- Excellent verbal, presentation, and technical writing skills.
Smiths Medical is an equal opportunity employer.
If you require assistance with our online job submission process, please contact our Talent Acquisition team at to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).
