Manufacturing Engineer
Education and/or Experience Required:
- Bachelor’s degree in an engineering discipline OR
- Bachelor’s degree in an unrelated field and 3+ years of experience OR
- Associate’s degree in physical science or mathematics and 5+ years of experience OR
- 8+ years of experience in an engineering position
Qualifications:
- Mathematics – Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
- Engineering and Technology – Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of electrical devices interfacing with physiological environments.
- Physics – Knowledge and prediction of physical properties, laws, their interrelationships, and applications to understanding material dynamics and mechanical and electrical structures, processes, and governing equations.
- Chemistry – General knowledge of chemical composition, structure, and properties of substances and of the chemical processes and transformations they undergo. This includes uses of chemicals and their interactions, danger signs, and disposal methods.
- Design – Knowledge of design processes, techniques, tools, and principals involved in production of technical plans, drawings, and models.
- Statistics – General knowledge of interpretive statistics and hypothesis testing for application within experimental methods.
- Complex Problem Solving – Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
- Equipment Selection – Determining the correct tools and equipment for an application.
- Installation – Installing equipment, machines, wiring, or programs to meet specifications.
- Quality Control Analysis – Conducting tests and inspections of products, services, or processes to evaluate quality or performance.
- Troubleshooting – Determining the root cause of operating errors as well as identifying and implementing appropriate solutions.
- Judgment and Decision Making – Considering the relative costs and benefits of potential actions to choose the most appropriate one.
- Systems Analysis – Understanding the function of a system and how changes in parameters, operations, and the environmental conditions will affect outcomes.
- Systems Evaluation – Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
Essential Duties and Responsibilities
Duties may include but are not limited to:
Design
Work is primarily involved with the creation of novel product designs or modification of existing products within Solidworks. Work may include selection and testing of materials or components to demonstrate a particular product satisfies design and user requirements. Work may include conceptualization and evaluation of a customer request for a particular product or design. The typical cycle includes conceptualizing, developing prototypes, testing, and transferring designs while remaining compliant to all relevant design controls according to 21 CFR Part 820 and ISO 13485. Design functions draw from both formal training and experience to appropriately apply engineering principles and concepts.
Circuit Design
Duties include applying circuit and instrumentation principles to understand and troubleshoot Ad-Tech electrodes and connection systems in the presence of hospital electromagnetic interference. Work may include remote and on-site clinical support, and where possible, the translation of new designs or user techniques to improve device usability and preserve biological signal quality.
Process
Work is primarily involved with the development or improvement of processes and may include selection and testing of methods to demonstrate suitability for a process. Work may include interaction with a supplier for a particular process or process equipment. The typical cycle includes equipment qualification, process characterization, process qualifications, and process risk analysis. Process improvement and development activities draw from both formal training and experience to appropriately apply engineering principles and concepts.
Other
Perform other related duties and responsibilities, on occasion, as assigned.
Work Context
Physical Demands:
- Requires repetitive movement and sitting for long periods at the desk
- Requires working indoors in environmentally controlled conditions
- Job tasks are performed in close physical proximity to other people
Desktop Computer Skills/ Tools:
- SolidWorks
- Microsoft Programs (Excel, PowerPoint, Word, Outlook)
- Mini Tab
Communication:
- Requires face-to-face discussions with individuals or teams
- Requires contact with others (face-to-face, by telephone, or otherwise)
Impact of Decisions
- Requires making decisions that may impact co-workers, clients, and the reputation of the company
- Opportunity to make decisions without supervision
- Includes responsibility for work outcomes and results
- Interpreting the Meaning of Information for Others
Pace and Scheduling:
- Requires meeting strict deadlines
Personal Interaction:
- Requires work with others in a group or team
- Requires coordinating or leading others in accomplishing work activities
Work Attire (When Entering Clean Areas):
- May require wearing common protective or safety equipment
- Clothing must be neat and clean
- Clothing or shoes cannot be made of shedding material (wool, angora)
- No sweaters are permitted
- Jewelry is discouraged in the clean areas
- Coverall or a non-soiled coverall
Environment
- Includes exposure to contaminants
- Includes exposure to sounds and noise levels that are distracting or uncomfortable