Summary of Responsibilities:
Under limited supervision, performs a variety of processes including chemical etching, laser welding, quality inspection and packaging to support production operations of medical device components of varying complexity, while minimizing scrap.
- Adhere to production schedules which are consistent with goals and objectives.
- Identify process issues and participate in the development and continuous improvement of manufacturing processes consistent with high quality and low product cost.
- Support various qualification, validation, and reliability studies in cooperation with manufacturing engineering.
- Works from WORK INSTRUCTIONS (WI), QUALITY INSPECTION PROCEDURES (QIP) and production/assembly instructions.
- Perform in-process and final quality control checks on components.
- Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and laser welding equipment.
- Interact with support groups to maintain production schedules.
- Work with engineers and technicians to resolve line issues and suggest improvements.
- Maintain accurate records/documentation, including Output charts and sales order status board.
- Adhere to general safety rules, manufacturing procedures, company policies and procedures and other ISO regulations.
- Maintain knowledge of current methods and techniques used in manufacturing.
- Work required overtime.
- Perform other duties as assigned.
1. Education and Training
- A High school diploma or equivalent combination of training and experience is required.
2. Required Experience
- Ideally a minimum of 1~2 years of related experience, preferably including two areas: directly related medical device manufacturing, machining and quality control.
- Essential Skills and Abilities
- Knowledge of and ability to operate SMALL hand tools (such as CALIPER, MICROMETER, MICROSCOPE) and STANDARD chemical process equipment.
- Ability to read and follow production/process instructions.
- Ability to work independently, using good judgment, initiative and problem-solving abilities, to follow detailed verbal and written instructions, anticipate likely needs and take appropriate actions, while working with minimal direction.
- Ability to work as a team member; flexibility, adaptability, and ability to work under pressure to meet schedules and deadlines within quality standards.
- Excellent interpersonal skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with a variety of personal contacts within the organization.
- Requires proficiency in speaking, reading, and writing in English; good arithmetic skills and attention to detail to maintain records and read instructions.
- Conscientious and self-motivated approach to work assignments and in matters of personal work organization, record-keeping, following instructions and maintaining quality standards.
- Regular and punctual attendance and dependability in meeting commitments and deadlines are essential functions of this position.
- Must be available and willing to work flexible schedules, as needed.
- Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must have the ability to maintain the physical condition, mental attention and abilities, and stamina appropriate to the performance of assigned duties and responsibilities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position requires a high level of hand-eye coordination and manual dexterity to work with small components in a high volume manufacturing setting.
While performing the duties of this job, the employee frequently will be required to do the following:
- Sit, sometimes for prolonged periods: while working at a microscope or at a work bench on a regular basis, sometimes for a significant portion of the day.
- Significant physical abilities include reaching, hand and finger dexterity, walking, standing, talking, hearing conversations, occasionally stooping or kneeling, and visual acuity.
- Perform multiple routine and semi-routine tasks; perform repetitive motion activities; work effectively as part of a team; and concentrate on a variety of details when faced with interruptions and changing work priorities.
- Working with chemicals, or finished materials, wear safety glasses, gloves, and/or other assigned safety equipment.
- The mental demands are representative of those that must be met by an employee to successfully perform the essential functions, as described above, including but not limited to: demonstrated ability to recognize and solve practical problems; reason, follow general instructions on routine work and detailed instructions on new assignments; comply with procedures and safety rules; and meet schedules in a dynamic and sometimes demanding work environment, while maintaining positive relationships in a team environment.
- The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job in a manufacturing environment the majority of the time.