דרושים Project Manager Specialist Iii Heredia ב-Boston Scientific ב-Costa Rica, Heredia

Costa Rica-Heredia

Hybrid Roles:

Your responsibilities include:

Designs, develops, debugs, modifies, and tests electrical, software and imaging design solutions by using current tools, analysis techniques, and technologies.

Investigates, researches, and selects electronic circuits, components, tools, equipment using best practices.

Provides project support and executes activities to ensure the safety, quality, and compliance for the design of products while continuously improving their commercial value through end of life.

Partners with technical leaders to solve technical problems using theoretical analysis, experimentation, and problem-solving methodologies to make data-based design decisions.

Coordinates with internal functions and external suppliers to identify and execute projects to deliver high quality engineering solutions at an accelerated pace.

Ensures products are compliant to electrical safety standards and other regulatory requirements.

Supports design of standard engineering tests and experiments.

Performs troubleshooting on products and manufacturing processes as related to design, material, or process.

Summarizes, analyzes, and draws conclusions from test results.

Documents product development by writing reports, memos and change requests. Methods used are determined by approved procedures and standards.

Tracks product development effort by creating and maintaining records in the approved tracking management tool.

Supports design transfer activities between Product Development and Sustaining Engineering

What we are looking for:

• 2+ years related experience; Experience in a regulated medical device environment preferred.
• Degree in Electrical Engineering, Mechatronics,Biomedical Engineering, or other related field (computer, systems). Bachelor’s or above required.
• Effective communications/presentation skills to all levels of the organization (both written and verbal)
• Experience in all areas of responsibility is not required. A strong aptitude and willingness to learn is required.
• Less than 10% travel.
• Preferred English Level: 80-89% +
• Please submit Resume in English.

Costa Rica-Heredia

About the role

Seeking a skilled System Verification Engineer (III) to join the Boston Scientific Neuromodulation R&D team. As a key member of the team, you will play a crucial role in ensuring the reliability and performance of our neuromodulation systems through rigorous verification processes. You will work closely with cross-functional teams to verify features and system functionality against design requirements. Your expertise will contribute to the development and execution of comprehensive system level design verification strategies, while collaborating with stakeholders to define design requirements and test methodologies.

This is a Hybrid role, located in Heredia and will require 3 days per week in the office.

Execute System Design Verification:

• Conduct verification of implantable and external Neuromodulation Product Systems with a focus on hardware/software integrated systems.
• Develop and execute verification plans, protocols, and test cases to ensure product compliance with design specifications and regulatory requirements.

Support Cross-Functional Verification Efforts:

• Collaborate with cross-functional teams, including hardware, software, and system-level testing, to support verification activities.

Develop and Maintain Verification Tools and Processes:

• Assist in the development and support of verification tools, test environments, and automated test systems.
• Help create, establish, and document verification processes and methodologies, and provide support for validation and verification activities.

Translate Requirements into Verification Plans:

• Ensure that verification strategies cover detailed verification design requirements effectively.

Identify and Mitigate Technical Risks:

• Identify technical risks and assist in developing risk mitigation plans. Implement phased verification approaches to mitigate risk and support the creation of documentation as part of the Product Development Process (PDP) and Quality Management System.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personal, tools, etc.) are maintained 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.

Minimum Requirements:

• Bachelor’s degree or more from an accredited school in Electrical Engineering, Computer Engineering, Electromechanical Engineering, Systems Engineering, Computer Science, or related field.
• 3+ Years of work experience in engineering with a Bachelor’s degree,
• 1+ years of work experience in Systems Verification.

Understanding and Evaluating Design Requirements:

• Ability to understand, properly interpret, and evaluate whether a design requirement is properly written.

Experience with Automated Testing Frameworks:

• Proficiency in using automated testing frameworks is essential for efficiently conducting verification tests and ensuring the reliability and performance of the systems.
• Experience with version control systems (e.g., Git), Dev Ops and CICD methodologies.

Programming/Scripting Knowledge:

• Knowledge of programming and scripting languages such as Python, C++, LabView, and Matlab for developing and executing verification tests, as well as for automating various aspects of the verification process.

Understanding of Electrical Engineering (EE) Concepts:

• Solid understanding of EE concepts, including Ohm's law, digital signal processing (DSP), and analog/digital electronics.

Proficiency with EE Test Equipment:

• Fluency in using EE test equipment like oscilloscopes, function generators, and data acquisition (DAQ) equipment.

Desired Requirements:

• Understanding of hardware-software integration.
• Experience working with complex HW systems, ideally implantable or capital medical products.
• 1+ years of experience designing verification strategies for systems-, sub-systems, system interfaces, and integration.
• Experience in system characterizations and trade-offs analyses (Ex. power budgets, data storage/transmission, battery selection, BLE antenna designs, lead/electrode designs for various use cases).
• Experience with software products both as a Medical Device (SaMD) and in a Medical Device (SiMD).
• Experience with Data Privacy and Cybersecurity for connected medical product systems.
• Experience collaborating with hardware, mechanical, electrical, algorithms, and software teams.
• Experience in algorithm and firmware development and product implementation.
• Experience with hardware-cloud-app systems.
• Experience in medical devices, aerospace, electronics, or other advanced technology and/or regulated industries.
• Experience with advanced statistics, including T-Test, ANOVA, Gage R&R, Design of Experiments (DOEs), etc.

Costa Rica-Heredia

Hybrid Roles:

Key Responsibilities

• Supervise the HRSD Support team (to be organized by country/language).
• Act as a team leader: ensure onboarding activities, presence, availability, access rights, tools, etc.
• Participate in the development of a Service Delivery cross-training plan and ensure team members become appropriately trained.
• Escalation points for support team to resolve complex issues.

• Monitor tickets, activities & performance of the team daily.
• Ensure strong quality as well as productivity standards & accountability within the team.
• Coach team members to drive improvements and service standards.
• Build strong relationships with key customers & partners (HR Service Center (HRSC), Employees & HR community) to meet end-user expectations.
• Partner with the HRSC and LATAM HR Team to the tiered governance structure.
• Execute continuous improvement activities across HRSD Support Team and support HR Center of Excellence (CoEs) to improve core HR processes.
• Support Service delivery analysts in issue resolution by providing information on root-cause analysis and execute intervention plans to address issues systemically. Act as point of escalation for any issue resolutions with HR services provided.
• Participate in and represent LATAM region in regular HR Service Delivery activity/performance review meetings.
• Ensure work is supported by appropriate documentation which is reviewed, updated, and maintained on a routine basis.
• Partner with Regional Process Lead to ensure appropriate processes are in place.
• Support optimization and updates to HR processes (methods & procedures) working with the HRSC.
• Track Service Level Agreements (SLAs) and measure achievement against team/individual performance criteria.
• Monitor cases to ensure quality and consistency across LATAM by providing feedback and coaching HR Service Delivery Support team where necessary.
• Ensure services are delivered in compliance with corporate policies and procedures or any other federal / country regulation as requirements.
• Ensure that the HR Service Delivery Support team prioritizes activities in accordance with SLAs/Key Performance Indicators (KPIs).
• Oversee the dispatching of cases within the HRSD Support team.
• Monitor the volume of cases and activities against available resources.
• Escalate and solve difficult cases and manage customer relationships where necessary.
• Lead, develop and coach Support the team in their professional development needs by ensuring they receive ongoing regular feedback, training and help in identifying, supporting and achieving agreed development objectives.

Qualifications:

• Bachelor’s degree in Human Resources, Business Administration or related field.
• At least 5+ years of experience preferably in Talent Acquisition, Total Rewards, Benefits administration, HR Shared Services.
• Experience managing and coaching a team.
• Language skills required English level C1 and Portuguese highly desired.
• Strong communication and writing skills in English and desirable in Portuguese.
• Experience with Workforce and case management systems, preferred experience with SuccessFactors and ServiceNow.
• Experienced in MS Office Applications (Excel, Word, PowerPoint).
• Analytical & problem-solving skills.
• Please submit resume in English.

Additional Qualifications & Competencies:

• Customer service orientation: ability to provide excellent support and service to internal and external clients
• Attention to detail: Ensuring accuracy and thoroughness in all tasks
• Team Collaboration: Ability to work effectively within a team and across departments
• Adaptability: Flexibility to handle changing priorities and workloads
• Leadership skills: ensure and assist the team to achieve business goals.

Internal candidates requirements:

• A year in the current position, in the company.
• Performance Evaluation: Successful or above
• Don't have disciplinary actions in the last 6 months.

Hybrid Roles:

Key responsibilities include:

• Leads quality team in sustaining activities to support commercial product monitoring on projects of major magnitude and scope. Key Quality voice of influence on projects.
• Leads quality team on functional deliverables and ensures technical excellence for product or technical development.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP.
• Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Maintains and enhances cross-functional team relationships.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.

What we're looking for in you:

Required Qualifications:

• Minimum of a Bachelor's degree
• Minimum of 7 years of related work experience or an equivalent combination of education and work experience
• Proven technical leadership and project management skills in medical device design, development, and commercialization
• Proven independent critical thinker, strong communication skills, strong presentation skills, and ability to build effective cross-functional relationships
• Ability to interface with customers to gather insight and get organizational buy-in on key design inputs
• Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations
• Medical Device or regulated industry experience

Preferred qualifications:

• Bachelor in an engineering discipline
• Advanced degree in technical field or business.
• Experience leading technical teams.
• Experience with Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
• Familiarity with BSC products and customer needs

Costa Rica-Heredia

About the role:

• The Principal Project Manager role will play an integral part in leading Sustaining/product integration projects within the Peripheral Interventional (PI) and/or Interventional Cardiology (IC) Division. Scope of projects includes all product support activities from initial launch to product end of life across PI business units and manufacturing sites. Project size ranges from small one-off tasks to large process improvement, design change, design transfers, line extension and projects/Corporate initiatives driving global productivity.
• Work directly with supporting cross-functions across business units and manufacturing sites. Cross-functional teams include, but not limited to, Research & Development, Design Assurance, Packaging, Regulatory, Process Development, Operations, Supplier Engineering/Quality, Supply Chain and Clinical.

Project/Program Management:

• Develops and implements overall project plan, including cost, schedule, risk and performance and monitors progress against business key objectives and goals.
• Identify prioritization and resource needs for assigned projects and activities with supporting cross-functions.
• Identify, communicate and manage technical challenges and business risks.
• Drive and influence results by acting with speed, agility and adaptability, assigning clear authority and accountability while integrating and aligning efforts across manufacturing sites and cross-functions.

• Provides structured thinking to project team on overall approach and delegates as appropriate.
• Directs and trains key project management processes.
• Leads the team in appropriate decision making through strong influence and the ability to analyze options and implications.
• Investigate and develop approach/solution to address technical problems with project teams.
• Direct control over activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.

• Foster a diverse workplace that enables all team members to contribute to their full potential in pursuit of organizational objectives.

• Provide timely communication on project progress updates to all relevant cross-functions and levels within the organization, including presentations to senior leadership.

Communication:

• Responsible for team and cross-functional level communications.
• Responsible for elevating critical business decisions to the appropriate management boards and/or functional managers.
• Liaison between the team and the Business Planning Team/Franchise Leadership Team (BPT/FLT), as required.

Relationship/People Management:

• Lead, coach and help diverse and dispersed project team members to execute towards overall project goal(s).
• Provides input to cross-functional Managers/Directors on team and team member performance.
• Develops and maintains strong relationships with functional heads to drive success of project team members and overall team member contributions.
• Ability to develop cohesive and collaborative cross-functional teams throughout project lifecycle phases.

Product/Compliance Management:

• Directs and/or provides input to the technical approach on product design and process changes.
• Directs and/or provides input on compliance update/changes on processes and/or systems.
• Identifies, communicates, and manages project risk.
• Monitor and ensures compliance with company policies and procedures (i.e. federal/country and regulatory requirements).

Process Management:

• Product lifecycle process knowledge to deliver and to maintain high quality and high impact deliverables.
• Knowledge of quality system use for the creation and continued compliance of products.
• Actively reviews policy and practice improvements to drive functional excellence.
• Influences cross-functional systems effectiveness.
• Financial management, including budget, forecast, and strategic plan input and preparation.

Key Leadership Competencies

• Strategic Thinking
• Communication
• Planning
• Influence

What we’re looking for:

Minimum Qualifications

• Bachelor’s degree required, preferably in Engineering or Project Management.
• More than 8 years of relevant experience, preferably within medical device industry.
• Small and large cross-functional project team lead experience.
• Must be willing and able to travel internationally ~10% of the time.
• Works under minimal supervision.

Preferred Qualifications

• PMP certification.
• Previous Sustaining and/or product integration experience and/or knowledge.
• Demonstrated ability to lead and work together with a cross-functional, multi-site sites.
• Strong organization, execution and communication skills.
• Candidate to be comfortable in front of all levels of the organization as well as external customers.
• Candidate to have strong leadership and interpersonal skills and ability to build relationships within project teams.
• Problem solving technical expertise.

Costa Rica-Heredia

Hybrid Roles:

Your responsibilities include:

• Project/Program Management: Manages key initiating, planning, executing, controlling, and closing processes; develops and implements project plan; builds team ownership and commitment to project plan. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort. Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project. Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans. Identifies and manages project dependencies and critical path items while ensuring project quality and utilizing and following appropriate methodologies (e.g. PLCP). Assures project quality by using standard development methodologies. o Communicates project status by preparing standard status reports, and by participating in project status update meetings. Resolves project issues by working with team members, project customers, and others as appropriate. Consults with internal project groups by sharing project management knowledge. Conducts project post mortems and communicates lessons learned in order to identify successful and unsuccessful project elements. Participates in external project management organizations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.
• Led cross-functional, multi-dimensional product development teams from concept through Launch; through proper execution of design controls that include an efficient transfer of newly developed products from Global R&D to manufacturing and global marketing through the BSC-defined PDLC processes to achieve project closure.
• Acts as liaison with other functions/sties for projects site is a contributor or stakeholder in.In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What We’re Looking For:

• Licenciature degree or above in Mechanical Engineering, Electrical Engineering or Field Related.
• English Level required: C2:(95-100%).
• Desired knowledge: Risk Management/ Risk Mitigation, Program Management, External Regulations (p.e. Quality, Systems) Master Degree in PM or equivalent, PMI certified PM.
• At least 10 years of experience in similar position.
• Please submit Resume in English\

Costa Rica-Coyol

About the role:

The Program Safety Specialist II is responsible for managing adverse events, device reporting, and safety deliverables for investigational and marketed products in the Rhythm Management division. This includes authoring and ensuring the execution of project-specific safety plans and overseeing event and complaint processing in accordance with study-specific operational plans.

Your responsibilities will include:

• Develop and author study-specific safety documents and plans (e.g., Safety Plan, Complaint Plan, CEC/IMR Charter).
• Assess the type and level of processing required for adverse events.
• Manage adverse event processing, including report reviews, safety query resolution, and expedited reporting.
• Perform medical review and assessment of adverse events in clinical trials.
• Participate as a core team member in clinical study teams.
• Lead Clinical Trial Safety Review meetings.
• Ensure adjudication and reconciliation of safety events prior to data snapshots, as applicable.
• Provide safety-related input for study documents and processes (e.g., protocol development, CRF design).
• Ensure timely delivery of functional safety outputs to support study milestones.
• Oversee additional projects and deliverables within and outside the department as needed.

Required Skills:

• Effective verbal and written communication skills.

• Strong analytical kills for identifying and addressing safety-related issues.
• Exceptional organizational and time management skills to prioritize tasks and meet deadlines.

Required qualifications:

• Bachelor’s degree (or equivalent) nursing, science or related field.
• Minimum of 3 years in clinical/scientific research, medical device, or clinical trials experience.
• Advance English Level
• Please submit resume in English

Preferred qualifications:

• Knowledge of device therapies in Electrophysiology, Watchman and Rhythm Management.
• Experience in processing and assessing safety events in clinical trials.
• Familiarity with Good Clinical Practice (GCP) guidelines.
• Knowledge of applicable safety regulations, including ISO 14155 and 21 CFR 812.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!