דרושים Quality Engineer Iii - Cartago ב-Boston Scientific ב-קוסטה ריקה

Costa Rica-Heredia

About the role:

As a Principal Engineer, you will be part of a high-performance team dedicated to support the commercial phase of disposable medical devices in the electrophysiology space. This role is integral to best-in-class development practices and rigorous, holistic product design—collaborating closely with internal and external partners to bring innovative solutions to patients.

Your responsibilities include:

• As an individual researcher, drives complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in the development of new or refined technologies, products, materials, processes, equipment, and or scientific methods.
• Uses knowledge and skills and is regarded as a knowledgeable and experienced resource who can quickly generate unique and creative solutions to technical challenges that the team cannot otherwise resolve.
• Assesses the feasibility and soundness of alternative engineering processes, products, or equipment when necessary data are insufficient or confirmation by testing is not advisable.

• Researching, designing, and evaluating mechanical and electro-mechanical materials, components, assemblies, and processes.
• Leading complex single-use device sustaining efforts including requirements, design, prototyping, testing, manufacturing transfer, V&V.
• Developing solutions to challenging engineering problems requiring ingenuity and collaboration across functions.
• Analyzing system-level issues and driving technical decision-making in cross-functional teams.
• Ensuring compliance with the Design Control deliverables throughout all the phases of the product life cycle.
• Esuring compliance with country specific regulatory requirements, such as FDA, EU MDR, among other.
• Integrating product-level documentation with broader system requirements.
• Organizing and planning project assignments with a focus on technical excellence and timely delivery
• Driving continuous improvement in product development and ensuring compliance with quality systems.
• Providing mentorship, technical guidance, and fostering a high-performance team culture.
• Drafting and submitting intellectual property.
• Maintaining detailed documentation throughout all research and development phases.
• Communicating effectively with internal stakeholders and external partners.
• Building strong cross-functional relationships to advance program goals.

What we are looking for:

• Bachelor’s/Licenciature Degree: Mechatronics, Electronics, Electrical, Mechanical, Materials Science, or related field.
• English level: +90%.
• Experience: Minimum of 7 years' experience in the medical device industry with a BS/Licenciature, Master/PhD degree is a plus.
• Knowledge of ISO 13485, EU MDR, and FDA medical device requirements, including design controls, product life cycle, validation/verification activities, and process improvement.
• Experience with Design Controls and Product Development Process in medical devices
• Proven experience managing technical aspects of cross-functional project teams
• Demonstrated ability to collaborate across functions and influence without authority
• Strong passion for understanding and solving problems for end users
• Excellent verbal and written communication skills
• Ability to travel internationally.
• Work Mode: Onsite.

Additional Preferred qualifications:

• Proven self-starter with ability to navigate ambiguity and lead teams through complex challenges
• Experience with electrophysiology devices and/or Class II or Class III medical device development
• Background in catheter design and understanding of cardiovascular anatomy
• Demonstrated leadership in product development and technical team management
• Ability to synthesize diverse technical inputs and drive holistic solutions
• Systems engineering mindset with the ability to define unmet needs and translate them into solutions

Benefits • Life-Work Integration • Community • Career Growth

Hybrid Roles:

About the role:

This position operates during night shift hours, supervising Engineering and/or Technician activities that directly or indirectly support production operations or test laboratories. Develops, establishes and maintains quality methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Identifies, coordinates, and assigns project priorities based on business and department objectives. Ensures implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

You're Responsibilities include:

• Oversees daily functions and work flow to meet operational objectives, comply with all policies and procedures, assure safety, and achieve effective core metrics performance.

• Supervises the management of staff, including workforce planning, recruitment, shift schedules, skill and performance assessments, workload distribution, training, corrective action, recognition, and daily direction on work assignments and priorities.

• Identifies and resolves operational issues and manages addressing non-conformance matters. Recommends and implements process improvements.

• Serves as internal liaison for team operations, including preparing reports and presentations on functions and performance.

• Ensures that special projects are completed following established schedules and procedures. Interfaces with cross-functional teams on special projects.

• Performs other responsibilities as required.

What We’re Looking For:

• Bachelor’s degree in engineering (ie: materials, chemical, industrial or similar) could be in process.

• English Level desired: Intermediate.

• Experience: 3 years and 1 year in Incoming areas as coordinator or area lead.

• Or an equivalent combination of education and experience.

Desired knowledge

Technical & Quality Systems Knowledge

• SAP Quality Module: Deep understanding of inspection planning, material master data, and quality notifications.

• CAPA & Non-Conformity Management: Root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagram), CAPA effectiveness checks.

• Validation Protocols: IQ/OQ/PQ processes, statistical tools for correlation studies, GAMP 5 principles.

• Measurement Systems Analysis (MSA): Gauge R&R, calibration techniques, and metrology fundamentals.

• Document Control Systems: Proficiency in Agile, Trackwise, and document lifecycle management.

Operational & Strategic Skills

• Area Metrics & KPI Development: Designing dashboards, trend analysis, and continuous improvement tracking.

• Lean Six Sigma: Application of DMAIC, waste reduction, and process optimization.

• Purchasing & Budgeting: Vendor evaluation, cost-benefit analysis, and procurement processes for lab equipment.

• Payroll & Personnel Management: Basic HR systems knowledge, timekeeping, and performance evaluation.

Leadership & Training

• : Conflict resolution, delegation, and performance coaching.

• Training Program Development: Creating competency matrices, onboarding plans, and technical training materials.

Regulatory & Compliance Knowledge

• ISO 13485 / FDA 21 CFR Part 820: Understanding of medical device regulations and audit readiness.

• Risk Management: FMEA, hazard analysis, and risk mitigation strategies.
• Document Creation (WI/SOP): Writing clear, compliant procedures and work instructions.

Hybrid Roles:

About the Role:

The Quality Manager is responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site´s manufacturing processes. Provides support to Process Quality and Quality Engineering areas management. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs. Additionally, he/she is responsible for planning and supervising In Process Quality Engineers functions and activities.

Your Responsibilities Include:

• Coordinate Quality Engineering and In Process Quality Engineering areas engineers’ functions and activities.
• Provide support to new products/process transfer projects; review risk analysis (PFMEA) for the different processes.
• Plan, coordinate and execute projects oriented towards in process defects prevention.
• Design and implement process control strategies.
• Facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
• Review and/or approval of documents, investigations, extensions or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management.
• Provide technical support to the In Process Quality area and to other departments.
• Deliver training related to quality technologies.
• Coordinate with Corporation the implementation of projects related to the In Process Quality area.
• Create new procedures on In Process Quality and/or improve the existing in order to facilitate and assure regulatory compliance.
• Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company´s quality system: 803.5 Individual Adverse Event reports, 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.100 CAPA, 820.198 Complaint Files.
• Participate as a core team member in the new products transfer process, representing Quality Assurance areas.
• May act as NCEP System administrator for the area: tracking and keeping NCEP investigations related to the area closed; area MRB administrator; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executes and the impact on other areas.
• May provide support to the Quality Director in his/her responsibilities. Authorized to sign as the Quality Director designee or representative in his/her absence or as required.
• Participate in the PIR (Product Inquiry Report) process, assuring: diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation. May act as the Quality Director (Head of Quality) designee in PIR process activities.
• May provide guidance and supervision to process validation areas, software validation complaint handling, MTAC, Calibration, Microbiology, supplier, Q process development, and/or design assurance.

What We’re Looking For:

• Licenciature degree in Industrial, Electronic, Biotechnology, Electromechanical Engineering or Field Related.
• English Level desired:90-94%.
• At least 10 years of experience in similar position.
• Desired knowledge: Formal training on statistical and quality techniques, desirable ASQ Certified, Knowledge of Six Sigma, Lean, APQP or similar tools.

Benefits • Life-Work Integration • Community • Career Growth

About the role:

This is a highly visible opportunity to serve as the Integration Developer delivering strategic initiatives supporting the HR function. You will own the integration development and implementation responsibilities for our SuccessFactors Integrations product team that designs, develops, tests, deploys, maintains, integrations that flow data to/from our HR platform successfactors. Partnering with HR leadership, and product management team you will be responsible for implementing and supporting various integrations. You’ll work across several globally dispersed teams on some of Boston Scientific’s most critical strategic projects. You will be instrumental in achieving our organization’s goals.

Your responsibilities will include:

• Design and implement integration flows using SAP CPI and BTP.
• Collaborate with functional and technical teams to gather requirements and translate them into integration solutions.
• Develop and maintain APIs and middleware components for HR applications.
• Monitor and troubleshoot integration issues, ensuring high availability and performance.
• Participate in code reviews, testing, and deployment activities.
• Document integration designs, configurations, and support procedures.
• Ensure compliance with data security and privacy standards.
• Ensure that the HR system and related processes meet all applicable compliance requirements
• Ensure adherence to BSC Global Systems methodology and SOX controls
• Ensure Production support tickets are handled within the agreed SLAs
• Work proactively on achieving the VIP goals set for the team.
• Support teams’ growth in Scrum/Kanban methodologies as well as conduct Scrum ceremonies to support enterprise delivery transformation model
• Provide product team reporting/dashboard(s) for senior management in a timely manner

Minimum qualifications:

• Bachelor’s degree in a related field (completed)
• 2+ year of Experience in Design and implement integration flows using SAP CPI and BTP
• 2+ years of Integration Development experience
• Experience in Product Teams and Agile SCRUM methodologies
• Advance English Level

Preferred qualifications:

• Experience in delivering results in large, cross-functional software initiatives
• Experience with SuccessFactors and data integrations processes
• Experience with SuccessFactors implementation and knowledge of different modules in SF
• Experience working on solutions in a controlled environment
• Proficiency in Microsoft Office: Word, Excel, and PowerPoint

Hybrid Roles:

About the Role:

Independently leads complex initiatives for the daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).

Your Responsibilities Include:

· May execute the following resposibilities:

· Drives complex or novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in the development of new or refined technologies, products, materials, processes, equipment, and or scientific method and may broaden BSC’s Intellectual Property in key strategic areas.

· Serves as a key resource or expert in one or more of the following: technology development, product design and development, test of materials, preparation of specifications, process study, and report preparation.

· Provides guidance to product, process, and technology teams.

· Influences decisions around alternative engineering processes, products, or equipment.

· Drives project goals and progress and influences appropriate revisions.

· Leads complex cross-functional teams or acts as an internal consultant to ensure successful completion of project goals.

· Trains, mentors, and/or provides work direction to technicians and engineers.

What We’re Looking For:

• Degree in Mechanical, Electromechanical, Electronic; Industrial; Biomedical, Chemistry; Industrial Maintenance, Business Administration or related.

• At least 7 years of experience in similar position.

• English Level desired:(90-94%).

• Desired knowledge: Process Validations, Stadistical and Experimental Analysis, DOE, Process Transfer; Problem Solving Methodologies (ex Six Sigma).

Benefits • Life-Work Integration • Community • Career Growth

About the role:

As the Field Action Team Lead within Global Quality Systems at Boston Scientific, you will play a critical role in managing and executing the Field Action process including Product Recalls, Field Safety Corrective Actions, and Safety Alerts. This position leads cross-functional Field Action teams, coordinating execution across multiple business units while ensuring compliance with internal quality procedures and external regulatory requirements.

This highly visible role requires strong project management, communication, and collaboration skills to effectively guide stakeholders including Business Unit Leaders, Quality Business Process Leads, Regional Field Action Coordinators, and other team members. You will oversee multiple Field Actions at various stages of completion, minimizing risks and ensuring timely, compliant execution.

Your responsibilities will include:

● Lead all phases of project management for Field Actions—planning, execution, monitoring, and closure—to ensure team accountability and on-time delivery.

● Prepare and manage project schedules, budgets, and deliverables using tools such as Microsoft Project; define and track key project tasks.

● Assign responsibilities, monitor progress, assess risks, and implement contingency plans to maintain quality and project integrity.

● Communicate project status through regular updates and meetings; collaborate across departments to address and resolve issues.

● Lead postmortem evaluations to document lessons learned and identify future improvement opportunities.

● Develop and maintain project plans for product changes and field action development, reporting key progress to senior leadership.

● Coordinate, finalize, and ensure compliance of all Field Action communications with internal and regulatory requirements.

● Support continuous improvement initiatives within the Field Action process.

Required qualifications:

● Bachelor’s degree and a minimum of 4 years' experience in a regulated industry (e.g., medical device, pharmaceuticals, or biotechnology); or Master’s degree with a minimum of 3 years' relevant experience.

● Minimum of 4 years' experience managing cross-functional projects, including scope, schedule, and budget.

● Strong background in post-market, field action (recall), and quality system processes.

● Proficiency in Microsoft Office and project management tools (e.g., Teams, PowerPoint, Excel, MS Project, Visio).

● Ability to travel 0–10%.

Preferred qualifications:

● Bachelor’s degree in communications, technical writing, or a related field such as science, health, or engineering.

● Effective communication skills, including experience engaging regulators, clinicians, and cross-functional stakeholders.

● Strong writing, editing, and presentation capabilities.

● Demonstrated problem-solving skills and ability to synthesize complex technical inputs.

● Strong organizational skills, attention to detail, and multitasking abilities.

● High emotional intelligence, situational leadership, and ability to influence across teams.

● Proactive, results-oriented mindset with a focus on quality and continuous improvement.

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Costa Rica-Heredia

About the role:

Evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Assignments have clear and specified objectives and require the investigation of a limited number of variables. Improve existing manufacturing processes and act as liaison between production and engineering group in resolving problems encountered on the production floor. Assist with the introduction of new products into the Operations production area.

Your Responsibilities Include:

• Participates in project teams typically including one of the following: identifying and implementing process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance; designing, performing, and documenting engineering test experiments to evaluate product/product performance; participating in Quality improvement activities; designing, developing, testing, and validating equipment, tools and fixtures; analyzing and interpreting process models and recommending process improvements; evaluates external process technologies; and other activities of limited scope requiring knowledge of principles and techniques commonly employed in the specific narrow area of assignments.
• Participate in equipment and process validation. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
• Participate in equipment and process validation. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
• Has working knowledge of Risk Management & Failure mode and effect analysis (FMEA) requirements.
• Interfaces with assemblers, production supervisors, and engineers in troubleshooting problems on the production floor.
• Coordinates with the appropriate suppliers and other external resources needed in developing and implementing process/product improvement plans.
• Acts independently to implement and follow through.
• Perform root cause analysis of failed product.
• Participates in project planning and scheduling.
• Optimize processes for yield improvements, cycle time improvements, and scrap reduction.
• Attends and contributes to product core team meetings.
• Performs responsibilities required by the Quality System and other duties as assigned or requested.

What we're looking for:

• Bachelor or Licenciature degree in Mechanical, Electromechanical, Electronic, Electrical Industrial Maintenance or related.
• Experience: At least 3 years
• English Level desired: 70-79%
• Technical Competencies: Problem Solving, Networking, Process Improvement, Lean manufacturing and Six Sigma knowledge, Process Validations.
• Knowledge of the Lab View programming
• Knowledge of automated vision systems
• Work Mode: Onsite.

Benefits • Life-Work Integration • Community • Career Growth