דרושים Analyst Sr Fin Data Mgmt ב-Boston Scientific ב-Costa Rica, El Amparo

Hybrid Roles:

About the role:

Plan, develop and maintain Post Market Surveillance compliance programs, policies, and processes. Create and champion improvement in the application of Quality System. Interface with key internal stakeholders including Corporate, Site, and Business Unit representatives. May serve as liaison between the company and various governmental agencies. Work directly with operating entities to ensure that Post Market Surveillance product complaint management processes are performed as required. May manage work done offsite and through 3rd party vendors. Work closely with CISs and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.

You're Responsibilities include:

• Recruit, coach and develop organizational talent.
• Provide oversight to work done offsite and by 3rd party vendors to ensure adherence to standards.
• Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
• Develop and maintain Post Market Compliance programs, policies, and processes.
• Develop and facilitate training and training support for the Post Market Surveillance organization.
• Work cross-functionally to identify and resolve issues.
• Determine appropriate staff levels, schedules and resources.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Drive projects of major magnitude and scope.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Provide solutions to a variety of technical and systematic problems of moderate to major scope and complexity.

What We’re Looking For:

• Bachelor's degree in Engineering
• English Level desired: B2+
• Experience: 10+ years
• Or an equivalent combination of education and experience.

Hybrid Roles:

About This Role:

As a part of the Global Systems & Processes team, the Sr Product Analyst will maintain and enhance global systems and processes to support quality goals and priorities for the Post Market Quality organization. This role is responsible for developing, establishing, and maintaining quality methodologies, systems, and practices to meet BSC, customer, and regulatory requirements. This individual will partner with stakeholders to recommend, design, and implement functional and technical process and system improvements, while enabling solutions that deliver valued business outcomes for Boston Scientific.

Your Responsibilities will Include:

• Partnering with an IT development team to support the launch and implementation of new system functionality; solicit business requirements, create user stories, and facilitate User Acceptance Testing (UAT)
• Performing qualitative and quantitative data analysis, opportunity assessments, and product experiments
• Analyzing and prioritizing requirements as a part of the overall Product Backlog
• Creating and publishing resources and information for the Post Market Quality organization
• Communicating process changes to users; developing and delivering user training and awareness sessions, as well as other global communications
• Providing support for the Post Market Quality organization to ensure defined quality goals and objectives are met
• Leading and participating in large-scale cross-functional, high-impact projects

Required Qualifications

• Bachelor's degree in any discipline with at least 6 years related work experience
• English Level: B2+: 80-89%
• Medical device quality experience
• Experience with system management, process analysis and development
• Experience with change management
• Proficient with Microsoft Office Suite and SharePoint
• Ability to travel globally, up to 15%

Preferred Qualifications

Note:Work samples will be requested as a part of the hiring process for this role.

• Ability to communicate effectively with individuals on all levels (written and verbally)
• Strong technical acumen with ability to collect, analyze and interpret business information and translate business needs into technical solutions
• Ability to work in a self-directed, fast-paced environment and complete work without significant guidance
• Strong problem-solving capabilities, high sense of urgency, and commitment to execution
• Ability to remain flexible and adaptable to changing needs and priorities
• Experience with Product Teams, Agile Scrum and Kanban methodologies
• Experience with Jira, Salesforce, Power BI or Tableau, SharePoint, Adobe Premiere, and/or Digital Adoption (Whatfix) software

Hybrid Roles:

You're Responsibilities include:

• Introduce and advance the Lean culture, principles and practices across the plant and work with local management to create and drive the Lean vision for the plant.
• Initiate and lead improvement projects (i.e. Lean, BPI, VIP) with the Production, Process Development, Manufacturing Engineering, and other support functions.
• Develop and conduct Lean training programs for employees at all levels and departments.
• Create, maintain and refine a Lean toolkit that can include: 5S, Kaizen, Value Stream Mapping, mistake proofing and line balancing.
• Deploy and support the use of corporate Lean tools and Metrics (Core Metrics, 5S, Lean Goals and Plans, etc.).
• Coordinate and lead engineering tasks, which may include: Creating and approving change requests, process optimization assessment, lead improvement project (as directed by site).
• Promote cross-functional and inter-site teamwork to accomplish shared objectives.
• Maintain a general knowledge of current Industrial Engineering trends and methodologies
• May supervise, mentor or provide work direction to other members of the Industrial Engineering team.

What We’re Looking For:

• Bachelor's degree in engineering.
• English Level desired: B2+
• Experience: 5+ years
• Or an equivalent combination of education and experience.

Hybrid Roles:

Your Responsibilities Include:

• Work with different service lines for SAP Ariba global support. Must have proven experience of global collaboration and outstanding customer service for internal and external clients at all levels of the organization.
• Define and achieve service lines objectives, policies, and goals. Maintain good relations with personnel under his/her supervision.
• Focus on continuous improvement through projects and initiatives from all personnel and regions.
• Assures and promotes great working relationships and support to BSC Suppliers, must have excellent negotiation skills.
• Promotes a work environment of knowledge sharing, ownership, and compliance to controls and objectives.
• Proven influence skills to increase and improve SAP Ariba buying channels usage.
• Project Management and prioritization capabilities.
• Excellent communication with all levels of the organization.

What We’re Looking For:

• Bachelor's degree in accounting, Business Administration or related
• At least 2 years of experience in similar position.
• English Level: 70% - 79%
• Strong and clear communication and collaboration skills.
• Require knowledge: Accounts Payable, Invoice Processing-Troubleshooting, POs reconciliations, 3way Match, SAP, Ariba
• Demonstrated experience managing and supporting change initiatives
• Desired knowledge: Free trade zone rules, SAP, knowledge in reconciling bank accounts and seats accounting, local and US accounting standard.
• Or an equivalent combination of education and experience

Hybrid Roles:

You're Responsibilities include:

• Analyzes customer complaints, events and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary.
• Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams.
• Documents trend action by updating the trend report at appropriate levels and by performing a Health Risk Analysis.
• Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.
• Provides input for process improvement and helps develops tactical approaches to implement team strategies.

What We’re Looking For:

• Bachelor’s degree in engineering
• English Level desired: B2+
• Experience: 6 + years
• Or an equivalent combination of education and experience.
• Desired knowledge:

Costa Rica-Coyol

Hybrid Roles:

Your Responsibilities Include:

• Leads a cross-functional team in driving alignment on project priorities, escalations, resourcing and timelines.
• Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Selects techniques to solve complex problems and make sound design recommendations.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Designs and prepares complex reports to communicate results to technical community.
• Designs and coordinates complex engineering tests and experiments.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
• Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices.
• Translates customer needs into product requirements and design specifications.
• Responsible for engineering documentation.
• Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
• May train and/or provide work direction to technicians and entry-level engineers.
• Demonstrates PDP/TPD system knowledge through delivery of high quality and high impact deliverables.
• Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
• Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.

For those individuals that supervise others, the following statements are applicable:Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

What we're looking for

• Experience: 2 to 5 years
• English level: 80-89% or above
• Licenciature: Mechanical, Electromechanical, Biomedical or related field
• Master degree desirable
• Problem solving
• Technical and Clinical Knowledge
• Networking
• Design control methods such as Risk Analysis (dFMEA, pFMEA)
• Design, Validation and Verification plans, protocol, and report generation.
• Medical Devices Industry experience
• PDP/TDP System
• Preferred Project management
• Please submit Resume in English