JOB DESCRIPTION

Purpose & Context
At LivaNova we unite to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for the Head and Heart.
Being a world leader in Cardiovascular and a leading player in Neuromodulation, LivaNova (approx. 3000 employees worldwide) is committed to applying its wealth of knowledge and technological expertise, acquired through decades of research and development to create therapies - products and services - that deliver the highest level of quality. Working with our organization is not just a career; it’s the chance to make a difference in the lives of more than one million patients every year, in over 80 countries.

As a part of the LivaNova Family you commit to uphold our Mission, Value and Pillars to;

• Put the Patient First
• Meaningful Innovation
• Act with Agility
• Commitment to Quality and Integrity
• Collaborative Culture

Alongside this, your purpose is to successfully assemble Perfusion Tubing System (PTS) Packs to the highest quality and meeting regulatory compliance for the manufacture of medical devices in accordance with organization policies and procedures and Australian Medical Device regulations, ISO 9001 and other relevant statutory requirements - ensuring they are complete on time.

Duties and Responsibilities

• Complete your allocated work to ensure production plans including daily volumes are executed and complete according to schedule, escalating as appropriate to ensure remediation activities deliver required outcomes.
• Assemble medical device set as per drawing instructions to the highest quality of product and compliance to all standards and regulations is achieved in the most efficient manner at optimal cost. Ensure all quality checks required are completed.
• Segregate and control assembled jobs to prevent mix-ups.
• Compliance with quality system documentation and ensure documentation and procedures are used as required. Notify Team Leader promptly of all proposed changes in and departures from standard Production processes.
• Support the Team Leader and your team by participating in the review of the following processes:
• Nonconformance reports
• Reprocessing
• Manufactured finished goods complaints
• Preventative and corrective actions
• Maintenance and calibration
• Testing and monitoring Results
• Training needs and identification, including for process changes
• Maintain area cleanliness as per Supervisor’s or Team Leader’s instructions.
• Recommend process and infrastructure improvements that support Right First Time outcomes to ensure we Impress our Customers and Create Business Value. Actively seek continuous improvement for self and all outcomes expected of role.
• Ensure that in-process and finished products are labeled, identified and segregated in Production to prevent errors.
• Ensure stock issued by Kitting is correct stock and quantity per batch paperwork.
• Compliance with LivaNova Occupational Health and Safety (OH&S), Regulatory, Quality and Environmental policies, procedures and work instructions as applicable to this position.
• Assist with training when requested.
• Manage spoilage within LivaNova target and plan to continuously improve KPI.
• Any other reasonable duties as required.

Behavioral Traits

• Respectful of Quality & Operate with Integrity
• Outcome Orientated Focus on achievement
• Dynamic and Forward facing, Engaged with our customers,
• Rich in Knowledge of our industry and Market place
• Entrepreneurial
• Accountable for our actions,
• Act with a sense of urgency
• Encourage communication
• Respectful of People and unified in our direction.

Reporting

• Batch paperwork

Authority to Act

• Applicable LivaNova policies and procedures
• Corporate Guidelines

Skill and Knowledge

• Cleanroom work or production assembly with 3 year’s experience in similar role.
• Effective team member.
• Strong emphasis on attention to detail.
• Good time management skills, ability to prioritise, proactively identify and mitigate risks.
• Ability to read technical information and/or drawings.
• Good problem-solving skills.
• Strong communication (both written and verbal).
• An understanding of production methodology principles including planning, raw materials, quality control, costs, operating procedures.

Valuing different backgrounds:
LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
Notice to third party agencies:
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
Beware of Job Scams:
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on
https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address

• Complete your allocated work to ensure production plans including daily volumes are executed and complete according to schedule, escalating as appropriate to ensure remediation activities deliver required outcomes.
• Assemble medical device set as per drawing instructions to the highest quality of product and compliance to all standards and regulations is achieved in the most efficient manner at optimal cost. Ensure all quality checks required are completed.
• Segregate and control assembled jobs to prevent mix-ups.
• Compliance with quality system documentation and ensure documentation and procedures are used as required. Notify Team Leader promptly of all proposed changes in and departures from standard Production processes.
• Support the Team Leader and your team by participating in the review of the following processes:
• Nonconformance reports
• Reprocessing
• Manufactured finished goods complaints
• Preventative and corrective actions
• Maintenance and calibration
• Testing and monitoring Results
• Training needs and identification, including for process changes
• Maintain area cleanliness as per Supervisor’s or Team Leader’s instructions.
• Recommend process and infrastructure improvements that support Right First Time outcomes to ensure we Impress our Customers and Create Business Value. Actively seek continuous improvement for self and all outcomes expected of role.
• Ensure that in-process and finished products are labeled, identified and segregated in Production to prevent errors.
• Ensure stock issued by Kitting is correct stock and quantity per batch paperwork.
• Compliance with LivaNova Occupational Health and Safety (OH&S), Regulatory, Quality and Environmental policies, procedures and work instructions as applicable to this position.
• Assist with training when requested.
• Manage spoilage within LivaNova target and plan to continuously improve KPI.
• Any other reasonable duties as required