Product Release Specialist jobs in United States
cer-icon
Apply on Employer Site
company-logo

Intuitive · 1 day ago

Product Release Specialist

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Product Release Specialist is responsible for reviewing device history records for accuracy and compliance, certifying product specifications, and ensuring proper documentation of manufacturing deviations.

Health CareManufacturingMedical Device
check
Growth Opportunities
check
H1B Sponsor Likelynote

Responsibilities

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

Qualification

Medical Device QMSRegulatory requirementsProduct Quality experienceAnalytical skillsProblem-solving skillsJudgmentEffective communicationDetail orientedTeam-orientedContinuous learnerInitiative

Required

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
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

Preferred

Bachelor's or Associate Degree Preferred

Company

Intuitive

twittertwittertwitter
company-logo
Intuitive designs and manufactures robotic-assisted surgical systems.

H1B Sponsorship

Intuitive has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)

Funding

Current Stage
Public Company
Total Funding
$5M
Key Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M

Leadership Team

leader-logo
Craig Child
Sr. Vice President, Human Resources
linkedin
leader-logo
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
linkedin
Company data provided by crunchbase