Essential Duties and Responsibilities

Department Specific Duties and Responsibilities

• Support the daily production and long-term goals of the manufacturing department.
• Perform all necessary related tasks with minimal supervision.
• Meet and exceed production and Quality expectations set forth in manufacturing.
• Follow all procedures in manufacturing, and provide input for process improvements.

Position Specific Duties and Responsibilities

• Perform all Total Artificial Heart (TAH) assembly operations, assemble all components and sub-assemblies in compliance with applicable written procedures.
• Perform required manufacturing tests in compliance with Quality requirements to insure optimal performance of finished product.
• Coordinate TAH assembly activities to meet required Quality criteria and customer and production schedules.

Role Specific Duties and Responsibilities

• Maintain necessary inventories of required component parts for TAH assembly to ensure optimal production efficiency and customer delivery.

Responsibility and Authority Affecting Quality

• Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
• Identify and record potential problems relating to the product, process and Quality System.
• Initiate, recommend or provide solutions through designated channels.
• Record and/or report all instances of customer feedback on product.

Position Requirements

Skills and abilities (required for the job)

• Operate all necessary equipment and tools required in assembly operations.
• Read and interpret drawings and specifications used in all aspects of assembly procedures.
• Excellent communication skills.
• Strong organizational skills.
• Detail oriented.
• Ability to handle multiple tasks simultaneously.
• A team player.
• Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
• Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Education, experience and training (required for the job)

• High school diploma or general education degree (GED), or one to three months related experience and/or training, or equivalent combination of education and experience.
• One year of manufacturing experience or equivalent.
• Basic Microsoft Office computer skills.
• Ability and willingness to identify requirements of internal and external customers and satisfy them in accordance with regulations and company Quality policies.
• Ability to develop and maintain positive working relationships with coworkers, supervisors, subordinates.

Working environment

• Work Station Area: Office, Controlled Environment Suite (CES)
• Special Factors in the Work Area:
• The position requires the ability to communicate in person, telephonically and via email.
• Occasionally required to stand, climb, balance, bend, stoop, kneel or crawl, work near moving mechanical parts, exposed to extreme heat or cold (non-weather), and lift/move 40 pounds.
• Frequently required to walk, and lift/move 10 pounds.
• Continually required to sit, utilize hand and finger dexterity, talk or hear, exposed to wet and/or humid conditions (non-weather), work around fumes, airborne particles, or toxic chemicals, and lift/move 5 pounds.
• The noise level in the work environment is usually moderate.
• Specific vision abilities required by this job include: Close vision/color vision/ peripheral vision/ability to adjust focus. Wearing contact lenses in the CES is prohibited
• Additional restrictions regarding work in the laboratory environment:
• No facial cosmetics or fragrances.
• Personal items stored outside lab (phones, jewelry, watches
• No food or drink at any time.
• Adherence to strict requirements regarding special and protective clothing.