Shire Connected Devices Operations Manager in Lexington, Massachusetts
The Shire Device Center of Excellence (DCoE) based in Lexington, Massachusetts allows Shire to explore how next generation therapeutics, emerging technologies and new care models can improve patient health. Our team shares a passion for challenging conventional wisdom and creating an environment that embraces the risk-reward aspects of developing breakthrough concepts. The DCoE offers a start-up environment with large company support. The DCoE works closely with research and development, commercial, device and drug product teams, and key external partners to drive early stage device/delivery system initiatives from concept to launch.
This Technical Team member will assist in managing the deployment of eHealth and Connected Health platforms and applications (e.g., mobile / web applications, infrastructure, middleware, and network, etc.). As a hands-on technical operations subject matter expert (SME), this person will assist in the day-to-day management of technical assets. Operational run activities will include maintaining the over-all platform health such as monitoring, performance, release management, and standard maintenance. The role will assist in operational activities across multiple device platforms and interact with multiple vendors (some platforms are 24X7). The role will be responsible for assisting in meeting all device Service Level Agreements (SLAs) and respond in timely manner to post-market questions and issues. Area of focus will include continuous improvement and automation of all aspects of the software medical device platform following good documentation practices and quality procedures. This role will follow the device design control and IT technical standards policies and procedures for delivery. This role will assist in audit / inspections and requires adherence to Shire’s compliance policies and procedures.
This individual is expected to have strong troubleshooting and scripting skills, Unix/Linux server administration experience, apache web administration and configuration, understanding of web applications and databases, and the ability to work with a globally distributed team.
Responsibilities (% of time):
Application Release deployments – project execution
Assist in the Dev/Ops organization overseeing the build, runtime configuration and deployment of the Spring Cloud Microservices, Spring MVC/Angular JS website, iOS and Android Mobile Applications, and MySQL and Couchbase databases.
Assist in providing quarterly reports of connected device performance / health
Assist in responding to post market surveillance issues (e.g., product complaints, CAPAs, FCA, etc.) – as assigned.
Assist in responding and implementing compliance changes in a timely manner.
Demonstrate work and team activities are aligned with all relevant quality, regulatory, and GXP requirements.
Collaborate with the support teams ensuring the health and availability of the non-production and production runtime environments.
Be a contributor of assigned cross functional team and contribute to the implementation of defined strategic initiatives for digital health and connectivity.
Technology Asset / Release Management
Responsible for maintaining release management calendar for routine upgrades and maintenance.
Responsible for maintaining comprehensive asset inventory.
Assist in the management of build tools (Jira, Jenkins, Maven, Artifactory, SVN, SonarQube).
Assessment / Continuous Improvement activities
Assist in providing input into the assessment of technologies as part of the long-range architecture based on pipeline and industry trends
Assist in the identification, development, and release of technical and operational improvement ideas
Assist in vendor management
Assist in vendor assessments
5+ years of technical experience in architecture and / or operational run activities (e.g., mobile / web applications, infrastructure, middleware, and network, etc.).
Experience in environment build, runtime configuration and deployment of key technologies across multiple applications / devices in production in global environment.
Experience in connected devices and / or regulated validated system development a plus.
Experience with Jira, Jenkins, Maven, Artifactory, SVN for Continuous Integration and Deployment (or similar tools).
Working knowledge of Cloud IaaS/PaaS.
Exposure to applying Security for Cloud Hosted Applications that handle PHI/PII data.
Experience in asset management and inventories a plus.
Experience in working with on / off shore resource support model
Experience in technical application development skills a plus.
Key Skills and Competencies:
Exposure to IaaS, PaaS, SaaS
Experience with Apache Web Server Configuration, understanding of Java Web Applications and databases
Experience with Jira, Jenkins, Maven, Artifactory, SVN, SonarQube or similar tools
Experience in working with globally distributed teams
Good written and oral communication skills
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.