דרושים Sr Production Manager ב-Boston Scientific ב-קוסטה ריקה

Your Responsibilities Include:

• Works with the corresponding functional and project managers to define project scope, strategy, timeline and budget associated.
• 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.
• Assures project quality by using standard development methodologies and by working with the corresponding Quality representatives to develop and execute project quality plans.
• Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.Resolves project issues by working with team members, project customers, and others as appropriate.
• Monitors and controls projects deliverables, and assures projects success through monitoring activities verifying activities completion and effectiveness.
• 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:

• Licenciature degree in Business Administration, Engineering or related.
• English Level: C1:(90-94%).
• Desired knowledge: certificacions (PMP, SCRUM, PgPM, PMI-ACP, PMI-RMP, PMI-SP), MS Office, MS Project, Planning, Execution, Problem Solving, Triple Constraint Management, Risk Management, Capex Management.
• At least 7 years of experience in similar position.

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

Key Responsibilities

• Lead strategic planning with senior executives to develop a comprehensive business strategy for Costa Rica and Central America, including market mapping and opportunity identification.
• Develop and execute integrated marketing plans to maximize market share, promote new product launches, and build brand awareness and customer loyalty.
• Conduct ongoing market research and competitor analysis to identify new opportunities and monitor market shifts.
• Collect and structure field information for updated market mapping and business sizing.
• Initiate and lead customer programs, networks, and advisory boards.
• Manage and oversee the regional marketing plan and budget.
• Lead and manage new product launches.
• Design and implement conference and symposium strategies to support the regional plan.
• Collaborate with sales managers to ensure sales representatives are adequately trained; organize physician and staff training, patient education events, and monitor post-training results.
• Select, develop, motivate, and retain a high-performing marketing team.
• Work with operations to manage supply chain for products, including forecasting, backorder management, and inventory planning for new products.
• Develop clinical activities plans, including registries and post-market studies.
• Quantify and prioritize reimbursement opportunities and execute related plans.
• Spend approximately 50% of time in the field supporting account conversion, product launches, clinical activities, and market intelligence gathering.
• Maintain regular communication with international/corporate marketing and sales/country management to ensure alignment.
• Ensure alignment with international functions (Finance, Supply Chain, Health Economics, Marketing, Clinical, Regulatory, Quality).
• Ensure compliance with standard operating procedures and champion quality and regulatory commitments.
• Promote quality awareness and guide the organization toward improved performance and customer-oriented initiatives.

What we are looking for in you:

• Bachelor’s degree in Marketing, Business Administration, or a related field.
• Fluent English.
• Experience working in sales organizations. (preferably in medical devices)
• Proven marketing and leadership experience of 5 or more years.
• Thorough practical knowledge of marketing theories, principles, and systems.
• Experience applying business and industry standards to achieve objectives.
• Strong problem-solving skills and ability to adapt plans to meet business challenges.
• Effective decision-making impacting finances, results, and service levels.
• Excellent communication and collaboration skills, with the ability to influence and guide others.

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.

Costa Rica-Heredia

Hybrid Roles:

Your Responsibilities Include:

• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.
• Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
• Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development
• Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation.
• Read and interpret technical drawings, procedures, and protocols
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
• Document investigation findings in analysis report on GCS2
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities

What we're looking for:

• Bachelor or Licenciature degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
• Experience: At least 5 years
• English Level desired: 70-79%
• Technical Competencies: ASQ Certified, Problem Solving, Networking

Benefits • Life-Work Integration • Community • Career Growth

About the Role

As the technical and operational leader, you will play a pivotal role in ensuring manufacturing excellence through continuous improvement, systems integration, and advanced troubleshooting. You will be responsible for sustaining process reliability, leading cross-functional teams, and guiding engineering excellence in a high-impact, regulated environment.

Key Responsibilities

· Lead sustaining activities for a complex, mission-critical manufacturing line with a focus on quality, delivery, and compliance.

· Serve as technical authority on integrated systems including PIMS, MES, Power BI, and PLC-based controls (e.g., Allen-Bradley, Siemens).

· Oversee and drive root cause investigations, implement corrective and preventive actions (CAPA), and lead structured problem-solving using DMAIC, 8D, and other lean tools.

· Manage real-time data analytics and reporting using Power BI dashboards, integrating information from MES and other manufacturing systems.

· Own and drive process validations (IQ/OQ/PQ) and ensure regulatory compliance in alignment with BSC Global SOPs and medical device standards.

· Collaborate with cross-functional stakeholders in R&D, Quality, Regulatory, and Supply Chain to resolve technical challenges and optimize line performance.

· Coordinate equipment troubleshooting and optimization, focusing on PLC signal interpretation and system interlocks to ensure seamless automation.

· Lead and mentor a high-performing sustaining engineering team, promoting a culture of technical excellence, ownership, and continuous improvement.

Qualifications

· Bachelor’s degree in mechanical, Electromechanical, Electronic, or Industrial Engineering.

· 5+ years of experience in manufacturing engineering in regulated industries (medical devices strongly preferred).

· Demonstrated success in leading product transfers and sustaining high-impact lines.

· Proficiency in PLC programming and troubleshooting (Allen-Bradley, Siemens).

· Deep understanding of MES/PIMS integration, with capability to leverage Power BI for advanced manufacturing analytics.

· Advanced knowledge of statistical analysis, process improvement, and validation (DOE, Six Sigma, Minitab).

· Strong communication and leadership abilities for cross-site coordination.

· Fluent in English C1+ (90%+).

· Master’s degree in engineering or related field.

· Six Sigma Black Belt Certification.

· Experience navigating SOPs for quality, transfers, and regulatory compliance.

· Take ownership of a strategically critical product with real-world impact.

· Be at the forefront of systems integration, digital manufacturing, and automation.

· Collaborate across global teams and mentor future engineering leaders.

· Work in a state-of-the-art facility with the opportunity to shape the technical roadmap for high-volume, high-quality production.

Costa Rica-Heredia

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Your responsibilities include:

• Lead and develop a team of engineers and technicians, fostering a culture of accountability, inclusion, and continuous improvement

• Provide direction and guidance to staff who exercise significant independence in their assignments

• Recruit, coach, and grow organizational talent while supporting career development and performance management

• Develop and execute operational policies and annual budgets for one or more functional areas.

• Ensure compliance with company policies and regulatory requirements (e.g., FDA, BSI, EEO)

• Build strong cross-functional relationships with Quality, R&D, Supplier Engineering, and Process Development teams

• Align resources and identify opportunities for improvement within existing systems and processes

• Communicate effectively across all levels of the organization, demonstrating leadership and transparency

• Influence and manage internal and external resources to achieve program and operational goals

• Serve as the engineering lead for one or more manufacturing value streams or functional teams

• Own the technical roadmap and execution strategy for the platform

• Lead the transition of technologies into production environments with a focus on scalability and manufacturability

• Define and implement process technology strategies aligned with business goals

• Facilitate and/or lead VIP, Kaizen, and Six Sigma projects to drive continuous improvement

• Promote world-class engineering practices and innovation in manufacturing processes

Minimum qualifications:

• Bachelor’s degree in engineering

• 5+ years in technical leadership roles, preferably in the medical device industry

• 3+ years of direct people leadership experience

• Track record of strong cross-functional collaboration, influence, and project management enabling highly effective project teams

• Ability to communicate technical issues and risks transparently and concisely across all levels of the organization
• Fluent in English and Spanish

Additional qualifications:

• A positive attitude and an innovative mindset

• Experience developing a company culture of knowledge-driven product development and engineering excellence

• Passion for understanding and solving problems and proficient in methodologies such as Six Sigma, DOE, etc.

• Passion for learning new technologies and finding new solutions

• Takes initiative and acts quickly to drive solutions

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!