דרושים Supervisor Ii Production Turno C ב-Boston Scientific ב-קוסטה ריקה

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.

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

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

Work Mode:

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in BSC Arbor Lakes, MN or Marlborough, MA.

Your responsibilities will include:

• Responsible for the development, in collaboration with the clinical trial team, of study-specific documents such as clinical protocol, clinical study reports and summaries, and clinical content that support the regulatory needs of a project.
• Reviews statistical output from BSC clinical trials and registries and determines appropriate evaluation, interpretation, and presentation of data.
• Responsible for the development, dissemination, and amplification of scientific clinical content in a variety of communication vehicles to ensure appropriate evaluation and presentation of data, interpretation, and alliance with business objectives.
• Writes manuscripts, as well as abstracts, slide presentations, and poster presentations for scientific meetings within and outside the U.S. in support of ICTx studies.
• Partners with internal and external authors (physicians/trial investigators) on manuscripts, conference abstracts, slide presentations and posters.
• Identifies gaps and opportunities for compelling evidence for relevant BSC products and therapies. Works with clinical and other functions (HEMA, R&D, marketing, etc) to identify solutions to the evidence gaps identified.
• Helps to organize and chair BSC study publication plan teams. Partners with investigators and internal BSC personnel to solicit feedback and develop clinical study-related publication plans. Serve as an advisor and expert for physicians needing to access relevant clinical content.
• Collaborates and provides input into clinical evidence strategy related to relevant BSC therapies.
• Interacts with marketing and other groups such as Scientific Communications to ensure that clinical data is represented accurately and correctly in any published literature, slide sets, and other materials prepared by these groups.
• Remains current with medical and scientific developments and publications on current/pipeline and competitor products, as well as maintaining a solid knowledge base of current data in relevant fields.
• Attends scientific conferences and programs in relevant therapeutic areas to maintain current knowledge.

Required qualifications:

• Minimum bachelor’s degree is required; and a minimum 3 years of experience (medical device, pharmaceutical, or biotechnology) in a related function such as clinical, research, marketing, medical affairs or product development or equivalent experience
• Proven knowledge of clinical issues associated with cardiology (structural heart, coronary therapies, and/or interventional heart failure) gained through direct or comparable relevant experience in a therapeutic area, scientific, or clinical setting
• Willingness to travel up to 10% travel domestic and international

Preferred qualifications:

• Solid understanding of scientific or clinical research and the scientific method, including interpretation of statistical results of clinical studies
• Demonstrated scientific/medical writing acumen (e.g., manuscripts, research grants, etc.)
• Ability to prepare and deliver scientific presentations, understanding of the structure and content of scientific presentations, ability to tailor presentation format and content to specific needs of topic and/or audience
• Knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practices

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.

Position Responsibilities:

• Coordinate, compile, and submit regulatory filings for new and modified products to Costa Rica and Central America Health Authorities.
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings;
• Monitor and assess regulatory updates for compliance with applicable regulations and impact to regulatory filings, communicate relevant changes to internal stakeholders.
• Collaborate cross-functionally with global and regional RA counterparts, legal representatives, commercial, marketing, and operations teams to ensure aligned execution of regulatory priorities and approvals.
• Maintain current and accurate information in regulatory systems regarding status, approvals, and product licenses.
• Develops and maintains positive relationships with regulatory agencies and industry associations through verbal and written communications.
• Coordinates localization process to guarantee Costa Rica and Central America labeling requirements are met.
• Provide regulatory input on promotional, labeling, and advertising materials in line with Central America regulations.
• Serve as the RA point of contact for consultants and distributors to ensure accurate and compliant submissions.

Required Qualifications:

• 3-5 years of experience as a Regulatory Affairs Specialist in medical devices in Costa Rica and Central America countries.
• Knowledge of Central American regulations.
• Bachelor’s degree in Life Sciences (Pharmacy, Biochemistry, Biomedical Engineering or associated areas);
• Advanced English;
• Attention to detail and ability to identify trends, gaps etc.
• Problem-solving skills;
• Ability to communicate complex ideas clearly and simply both verbally and in writing;
• Ability to effectively manage multiple projects and priorities;
• Team player with excellent interpersonal skills.

Preferred Qualifications:

• General knowledge of global or LATAM regulations is an asset.
• Experience with interactions with regulators: Regulatory Intelligence and Advocacy.

Costa Rica-Heredia

About the role:

Support the design and development of products, materials, process changes, or new technology for projects with moderate to high complexity. Under minimum supervision/guidance, research data, compiles, analyzes, and reports testing to establish technical specifications for designing or modifying products, processes, and materials.

Your responsibilities include:

• Successfully completes complex engineering work in one or more of the following: product design and development, complex engineering tests and design experiments, preparation of specifications, product capability studies, research investigations, and process/test documentation through the product lifecycle.
• Develop solutions to a variety of problems of high complexity and scope where analysis of situations or data requires a review of identifiable factors.
• Summarizes, analyzes, and draws conclusions from test results. Designs and prepares complex reports to communicate results to the technical community.
• 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, provide work direction, and supervise technicians and entry-level engineers.
• Works under general direction or within a team to complete projects and special assignments.
• Establishes and cultivates a range of business relationships to facilitate the completion of assignments. Influences project team and peers on business solutions.
• Cooperate in determining goals and objectives for projects. May lead projects within the function or department and/or represent the role in larger project teams.
• Performs troubleshooting on product problems related to design, material, or process.

What we are looking for:

• Bachelor's/Licenciature Degree: Mechatronics, Electronics, Electrical, Mechanical, Materials Science, Biomedical, Industrial, Chemical Engineering or related field.
• English level: +90%.
• Experience: +2 years in related positions.
• Knowledge of ISO 13485, MDR, and FDA medical device requirements, including design controls, product life cycle, validation/verification activities, and process improvement.
• Ability to travel internationally.

Work Mode: Onsite

Benefits • Life-Work Integration • Community • Career Growth

Job Title: CRM Field Clinical Representative

Role overview:

In this dynamic and patient-centered role, you will be a key clinical and commercial contributor—supporting our technologies through hands-on education, sales support, and expert clinical guidance. You’ll cover a defined territory, collaborating closely with hospitals and healthcare providers to ensure best-in-class outcomes and to drive the adoption of our innovative CRM solutions.

Your responsibilities will include:

• Serving as the primary clinical expert during device implants, patient follow-ups, programming, and troubleshooting
• Delivering impactful education and training to healthcare professionals on product use and clinical benefits
• Attending procedures in hospital labs and operating rooms to support optimal patient outcomes
• Building strong relationships with physicians, nurses, and key hospital staff to foster trust and drive engagement
• Resolving customer needs efficiently , collaborating cross-functionally to ensure patient and clinician satisfaction
• Managing product inventory according to company guidelines, ensuring readiness and availability
• Participating in a rotational 24/7 on-call schedule to support patients and clinicians in real time

Required qualifications:

• 0–2 years of work experience
• Bachelor’s degree in biomedical engineering, science, math, business, nursing, or equivalent technical field
• Willingness to support a rotating 24/7 on-call schedule, including nights, weekends, and holidays

Preferred qualifications:

• Experience in an electrophysiology (EP) lab, cardiac device clinic, or cardiac catheterization (Cath) lab
• Background in medical device sales, clinical education, or research
• Strong initiative and accountability in achieving goals independently and as part of a team
• Excellent communication skills with the ability to explain complex therapies and technologies clearly
• Passion for innovation, patient care, and collaboration in a fast-paced environment

The anticipated annualized base amount or range for this full time position will be$70,000 to $90,000plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.