Product Release Specialist

Primary Function of Position:

The Product Release (PR) Specialist is responsible for reviewing device history records (DHRs) for accuracy and completeness certifying compliance to product specification and traceability requirements and ensuring that any deviations from the manufacturing process were properly recorded and authorized by members of the appropriate departments. 

The Product Release (PR) Specialist receives guidance on workload prioritization from the team lead or supervisor but is ultimately responsible for organizing and executing their projects and daily standard workload in a manner which meets the schedules of the operational teams whom they support.

Essential Job Duties:

• Product Release
  • Reviews DHRs for da Vinci systems instruments and accessories for compliance to product specifications and company traceability requirements creating certification documents and authorizing release of product for distribution to customers and New Product Introduction (NPI) launches.
  • Reviews and approves records from sterilization sub-contractors to assure sterility of single use products.
  • Ensures that any non-conformances or deviations are properly approved and documented in the DHR.
  • Works collaboratively with internal customers to resolve DHR issues in a timely manner.
  • Reports on workload status regularly within the team and identifies issues which pose a potential risk to team goals.
• Performs inventory transactions and ensures that released products are transacted in a timely manner to maintain inventory accuracy for department inventory locations.
• Participates in department process improvement projects or other activities as directed by management.

Qualifications :

Required Skills and Experience:

• Team-Oriented: Approaches their work selflessly and without ego making an honest effort to manage their own assigned workload communicating openly and in a timely manner when deliverables are at risk and actively seeking opportunities to ask How can I help  Freely shares information and makes it a priority to mentor their peers when the opportunity presents itself. 
• Quick Study & Continuous Learner: Demonstrates aptitude for learning new processes quickly actively seeks deeper understanding of processes and functions critical to their role.  Strives to understand the bigger picture and how their role supports key company objectives.
• Perceptive & Detail Oriented: Skilled at sensing variations from the norm and thoroughly investigating whether compliance to company process has been maintained.  Demonstrates ability to execute competently and consistently to fundamental job skills while advancing knowledge in more complex disciplines.
• Initiative & Follow-through: Seeks opportunities to improve departmental process and expand personal contributions.  Can be relied upon to complete commitments without excessive follow-up.
• Good Judgment: Strong ability to draw correlations to prior experience and identify precedent in ambiguous circumstances.  Demonstrated track record of making good decisions.
• Ethical & Independent: Demonstrates recognition of the criticality of the job function and strives to conduct themselves in a manner which does not invite doubt about their ability to consistently execute process without direct supervision.  Does not cut corners or bow to external pressure to compromise on requirements. 
• Effective Communicator: Excellent verbal and written communication skills.  Skilled at making use of visual aides to convey complex concepts to diverse audiences.
• Exceptional analytical problem-solving and root-cause analysis skills
• Excellent verbal and written communication
• General familiarity with spreadsheet word processing and email software
• Understanding of or aptitude to understand Medical Device QMS and regulatory requirements including but not limited to ISO13485 and U.S. FDA 21CFR820

Required Education and Training:

• Must have a GED or high school diploma.
• 2 years of operational experience in a Product Quality or certified (e.g. FDA ISO Mil-Spec etc.) manufacturing environment

Working Conditions:

• Role is full-time onsite.
• Must be available to manufacturing teams and for specialized roles.
• Must be able walk long distances to validate release forms.
• OT will be required as needed per business need or per Supervisor/Manager discretion.
• Must be available to travel as needed 5-10%.

Preferred Skills and Experience:

• Bachelors or Associate Degree Preferred

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time