MAIN PURPOSE OF ROLE

Under general supervision, performs on-the-job, skill, and classroom training in assembly and production areas. Participates in the development and implementation of new training programs, and may introduce new processes and sequences for manufacturing areas. Maintains rosters of training progress, examination as well as certification records, and, in addition, may monitor trainees. Takes initiative to ensure work is done accurately and completely. Applies existing work methods to different known situations. Problems involve recurring, routine situations; usually refers more complex problems to supervisor or more senior level personnel.

MAIN RESPONSIBILITIES

•Provides instructional training and assessment/certification support for multiple processes (e.g., automated component attach operations; robotic and machine visual system (i.e., magnetic resonance spectroscopic imaging); wirebond, manual assembly, inspection, test and probe).

•Supports the development and administration of various training programs, e.g., production related modules.

•Contacts attendees and department representatives about training programs. Schedules the appropriate classroom and prepares the physical setup. (e.g., New Hire Orientation, Continuous Improvement training. and/or conducting limited classroom training).

•Partners with appropriate Engineering personnel in developing process yield improvement plans.

•Performs regular process audits of personnel, tooling and equipment in assigned areas. Performs inspection of batteries and disposition per required documentation. May be involved in generating audit action items and participating in the preventative and corrective action associated with audit findings.

•Participates in the development or improvement of process work instructions (i.e., Manufacturing Operation (MO), Engineering Specification (ES), Process Aid (PA)) and training modules (i.e., guides and assessments) in conjunction with Training, Quality, and Engineering.

•Reviews and recommends procedural changes pertaining to all applicable specifications, as well as, communicating all Engineering Change Orders (ECO’s) and Temporary Alert changes to production. Generates ECO’s as requested to facilitate changes.

•Maintains required records and assures operator compliance. Compiles and organizes data to support continuous improvement plans for both process area and individual work cells.

•Participates in the debugging of new automated assembly programs, tooling and new products in conjunction with appropriate Engineering personnel.

•Develops high level of proficiency in Manufacturing Execution System (MES) issues as related to assigned processes. Provides concurrent training to process trainees.

•Performs direct manufacturing operations in support of build schedules as needed.

•May set-up/utilize special test equipment.

•Notifies the department manager of the need to replenish supplies/materials and of any difficulties that cannot be readily corrected.

•Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.

•Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

•Assists trainees and team members in getting access to various computer applications and systems such as MES/FTPC and email.

QUALIFICATIONS

Education

Education Level

Major/Field of Study

Or

Education Level

High School Diploma / GED

GED or equivalent

☒

an equivalent combination of education and work experience In Electrical/Mechanical Technology, or comparable specialized training in and working knowledge of the manufacture of implantable medical devices or equivalent is desired.

Associates Degree (± 13 years)

Experience/Background

Minimum 4 years

Related experience in the assembly of digital and analog circuitry/devices, including the demonstrated ability to provide work/lead direction to a team.

Academic and/or in-house courses in project management, leadership, training, Continuous Improvement (CI), cycle time improvement, and various technical applications as noted above are highly desired.

Formal training in assembly techniques; experience with assembling manufactured items in a bio-instruments/bio-devices related facility are also highly desired.

Must be able to demonstrate comprehensive product assembly techniques, related process knowledge, plus a mastery of appropriate skill sets as confirmed by cognizant Engineering and/or Production/Quality Assurance supervisory personnel.

Demonstrated manual dexterity and hand/eye coordination is required.

Must be attentive to detail.

Demonstrated use of standard hand tools used in the assembly of bio-instruments/bio-devices is mandatory. Incumbents are required to work cooperatively and productively with others.

Must be able to multi-task, meet deadlines on multiple projects, and rotate through all jobs performed in the assigned work group as needed.

Incumbents are required to have demonstrated spelling, punctuation, grammar, basic math/numerical, organizational skills, and a familiarity with standard manufacturing/office equipment and procedures.

The ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech and demonstrated comprehension skills.

The ability to successfully pass a reading comprehension pre-employment examination is mandatory.

The demonstrated ability to provide constructive input/feedback to trainees and all levels of employees is also required.

The demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies and rules is essential.

Must be able to maintain regular and predictable attendance; the ability work overtime is also required.

Must have the ability to lift on occasion up to approximately twenty-five pounds.

Experience working in a broader enterprise/cross-division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Ability to leverage and/or engage others to accomplish projects.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.