Supervisor Sr Production Turno jobs at Boston Scientific in Costa Rica

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

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

Hybrid Roles:

Your Responsibilities Include:

• May execute the following responsibilities: 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.
• Knows and interprets Risk and Validation documentation to make sound decisions on potentially non-conforming product.
• Lead and provide guidance in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, and complaints
• Get involved in various stages of equipment, process and test method validations: Run and / or review and / or approve reports protocols and reports.
• Read and interpret technical drawings, procedures, and protocols
• Knowledge of statistical tools: SPCs, Capability Analysis, ANOVA, sampling plans, and others to make quality decisions on potentially non-conforming product.
• Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems.
• 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
• Provide supervision, leadership, and overall direction to the Quality team to ensure they are identifying issues, quarantining defective product, and efficiently moving product through the release process.
• Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, GMP's, Corporate and site level SOP's.

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:

• Bachelor or Licentiate degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field
• English Level desired: 70%.
• Experience: At least 2 years, Non conformances handling, CAPA, Quality manufacturing engineering, risk management, validations, and process engineering.
• Skills: teamwork, proactivity, goals oriented.
• Desired knowledge: ASQ certification (CQE, SSGB) desired, Problem Solving, Knowledge of QSR’s, Formal training on statistical and quality techniques desirable, Networking.
• Please submit Resume in English

Responsibilities Include:

• Support and develop a high-performance sales and clinical organization to effectively achieve Axonics’ business objectives.
• Provide daily guidance and leadership to the field team through effective communication of objectives, hands-on coaching, and team development.
• Support, develop, and execute territory plans to deliver on annual revenue commitment and build a sustainable business over the longer term.
• Provide day-to-day field clinical support, which includes patient interactions, patient education, programming of Axonics devices and patient follow up, plus technical/application and education support, site management, coordination and in-service training for the SNM clinical programs.
• Build strong relationships with existing customers and drive new business in the assigned territory.
• Drive effective sales and educational initiatives.
• Work effectively with Sales/Marketing/CCO/Product/Business Managers to design and execute strategic sales and marketing initiatives.
• Develop the market for our existing and new products in line with divisional goals and objectives.
• Proactively identify and communicate changes in the healthcare, delivery systems, and competitive pressures to develop and modify strategies and tactics accordingly.
• Attend clinical meetings, seminars, and conferences as appropriate.
• Established contact person for hospital management, purchasing department and hospital staff as it relates to Axonics SNM business.
• Hand in all reports including forecasts, expense reports, etc., in an accurate and timely fashion.
• Negotiate distribution agreements where required.
• Maintain all company assets, including assigned inventory, in good order and in accordance with BSC audit and process requirements.
• Successfully complete formal Axonics training program, apply these skills in the field and maintain high level of technical and market knowledge on an ongoing basis.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree.
• Minimum of 5 years in sales and marketing in health industry environment.
• Demonstrated ability to achieve both personal sales territory plan and plan for team.
• Proven business analysis and judgment with the ability to proactively manage business to meet objectives.
• Strategy development, project management, and problem-solving skills.
• Solid understanding of healthcare and regulatory requirements and issues.
• Ability to build positive working relationships, both internally and externally.
• Ability to effectively present information to all levels including management and C-level.
• Business related computer skills including Microsoft Office Suite.
• Ability to travel extensively.
• Fluency in English.
• Passionate, energetic, achievement motivated, high integrity make-up.

The anticipated annualized base amount or range for this full time position will beplus 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.