Jobs at Boston Scientific in Costa Rica, El Amparo

Costa Rica-Coyol

About the role:

Develop, implement, maintain and improve appropriate quality system elements to ensure the high-quality level of new and existing products. Provide guidance and support to NCEP and CAPA owners for documentation, timelines, and eCAPA system use. Provide guidance and support for other day-to-day activities within the department. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your responsibilities include:

• Provide Quality Engineering support for sustaining activities and improvement projects for commercial products, with a focus on Non-Conformance Event Prevention (NCEP) and Corrective and Preventive Actions (CAPA).

• Collaborate with NCEP and CAPA owners on documentation, timelines, and eCAPA system use, to prioritize tasks and ensure content is clear/well-documented.

• Perform failure analyses and defect investigations as needed. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues and approve material dispositions.

• Perform and/or lead risk analyses and failure investigations for CAPA and/or audit finding investigations. Act as an effective leader of team member in supporting quality disciplines, decisions and practices.

• Create, revise, and approve departmental procedures and quality system records. Lead in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.

• Design and implement Quality System processes, procedures, and techniques such as risk assessment, root cause analysis, etc.

• Monitor and track the progress of quality-related tasks and initiatives, with a focus on NCEP and CAPA records. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines.

Minimum Requirements:

• Bachelor’s degree in engineering, or a related field.

• 3+ years’ experience in the medical device industry with a solid understanding of QSR and ISO 13485 Quality System requirements

• English level B2 or above
• Excellent verbal and written communication skills

• Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio)

• Strong technical writing skills and ability to clearly communicate complex information

Preferred qualifications:

• Project/task management experience

• Experience with Product Lifecycle Management systems (i.e. Windchill, PLM)

• Experience with nonconformance and/or CAPA process

Hybrid Roles:

You're Responsibilities include:

• Introduce and advance the Lean culture, principles and practices across the plant and work with local management to create and drive the Lean vision for the plant.
• Initiate and lead improvement projects (i.e. Lean, BPI, VIP) with the Production, Process Development, Manufacturing Engineering, and other support functions.
• Develop and conduct Lean training programs for employees at all levels and departments.
• Create, maintain and refine a Lean toolkit that can include: 5S, Kaizen, Value Stream Mapping, mistake proofing and line balancing.
• Deploy and support the use of corporate Lean tools and Metrics (Core Metrics, 5S, Lean Goals and Plans, etc.).
• Coordinate and lead engineering tasks, which may include: Creating and approving change requests, process optimization assessment, lead improvement project (as directed by site).
• Promote cross-functional and inter-site teamwork to accomplish shared objectives.
• Maintain a general knowledge of current Industrial Engineering trends and methodologies
• May supervise, mentor or provide work direction to other members of the Industrial Engineering team.

What We’re Looking For:

• Bachelor's degree in engineering.
• English Level desired: B2+
• Experience: 7+ years
• Or an equivalent combination of education and experience.

Costa Rica-Coyol

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
• Support environmental monitoring, microbiology and product testing as in approved procedures and protocols.

Required Qualifications:

• Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field
• 0+ years of related work experience or an equivalent combination of education and work experience
• English language required B2: 70-79

Hybrid Roles:

About the role:

Plan, develop and maintain Post Market Surveillance compliance programs, policies, and processes. Create and champion improvement in the application of Quality System. Interface with key internal stakeholders including Corporate, Site, and Business Unit representatives. May serve as liaison between the company and various governmental agencies. Work directly with operating entities to ensure that Post Market Surveillance product complaint management processes are performed as required. May manage work done offsite and through 3rd party vendors. Work closely with CISs and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.

You're Responsibilities include:

• Recruit, coach and develop organizational talent.
• Provide oversight to work done offsite and by 3rd party vendors to ensure adherence to standards.
• Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
• Develop and maintain Post Market Compliance programs, policies, and processes.
• Develop and facilitate training and training support for the Post Market Surveillance organization.
• Work cross-functionally to identify and resolve issues.
• Determine appropriate staff levels, schedules and resources.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Drive projects of major magnitude and scope.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Provide solutions to a variety of technical and systematic problems of moderate to major scope and complexity.

What We’re Looking For:

• Bachelor's degree in Engineering
• English Level desired: B2+
• Experience: 10+ years
• Or an equivalent combination of education and experience.

Arden Hills, MN Onsite

In this role, you will lead design changes originating from product or yield improvements, Regulatory or supply chain needs. You will develop new technologies, products, materials, processes, or equipment with minimal supervision.

Key Responsibilities:

• Resolves urgent issues effectively, applying engineering knowledge to problem solve and support business in rapidly evolving situations
• Develops technology, product designs, testing of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Leads product improvement design activities
• Designs, coordinates, and analyzes complex engineering tests and experiments.
• Develops slide decks & reports and presents updates to management & technical community.
• Influences middle management on business solutions.
• Interfaces with Marketing and/or field personnel to obtain feedback on concepts and performance of new devices.
• Translates customer needs into product requirements and design specifications.
• Partners with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure success.
• May train and/or provide work direction to technicians and entry-level engineers.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors.
• May lead projects within the function or department and/or represent a specialized field in larger project teams.
• Uses discretion, diplomacy and tact to resolve difficult situations.
• Conducts root cause analysis of design related field complaints
• Support RA team with new markets registrations and regulatory submissions.

Minimum Required Qualifications

• Bachelor’s degree or more from an accredited school in Mechanical or Biomedical engineering or related field
• 7+ years of experience in engineering with a Bachelor’s degree OR 5+ years of work experience in engineering with a Master’s degree
• Experience as a hands-on design and project engineer in the medical device industry, responsible for new implantable device designs, materials, equipment, and processes.
• Hands-on experience utilizing SolidWorks 3D CAD and drafting standards (e.g., ANSI Y14.5)
• Experience executing projects through commercial launch
• Self-Starter with the ability to work independently to plan, schedule and execute activities necessary to meet project timelines.
• Ability to identify and solve problems with root cause analysis, including designing and executing experiments and using statistical methods to drive data-based decisions.
• Willingness to work onsite (4+ days per week) at our Arden Hills, MN site

Preferred Requirements

• Experience designing and evaluating test methods and fixtures.
• Ability to work hands-on with test systems and develop new test systems as needed.
• Working technical knowledge of implantable medical devices.
• Experience with commercialized product data management systems.
• PE licensure preferred; a minimum of EIT certification desirable.

Base Salary Range

Minimum Salary: $ 82600

Maximum Salary: $ 156900

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

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-Coyol

About the role:

Responsible for the efficient management of production resources: equipment, personnel and materials.

Your Responsibilities Include:

• Oversee operations efficiency and standardization.
• Directly responsible for complying with the production plan and the quality of the product, as well as for line personnel.
• Analyze and evaluate process improvements in order to reduce defects and scrap and/or improving yields.
• Follow procedures established for each operation, and keep work areas organized and clean at all times.
• Participate and/or lead problem solving processes, whether due to increasing trends on complaints, defects, scrap, or low productivity, among others.
• Provide feedback to PB IV.
• Support employee-safety oriented initiatives: rotation programs of line personnel, use of safety equipment in the production area, and EH&S awareness programs.
• Support EHS management system: responsible of understand, know and apply EHS policy. Responsible to acknowledge and inform the environmental aspects and health and safety risks relevant to mitigate, reduce and eliminate impact during operations.
• Monitor and update the department´s metrics: Yield, Efficiency, Plan Compliance, RCTIME and Quality.

What we're looking for:

• Bachelor or Licenciature degree in Business Administration, Industrial Engineering or Related Field.
• English Level desired: 70-79%
• Experience: At least 2 years
• Technical Competencies: Problem Solving Methodologies.

Hybrid Roles:

About This Role:

As a part of the Global Systems & Processes team, the Sr Product Analyst will maintain and enhance global systems and processes to support quality goals and priorities for the Post Market Quality organization. This role is responsible for developing, establishing, and maintaining quality methodologies, systems, and practices to meet BSC, customer, and regulatory requirements. This individual will partner with stakeholders to recommend, design, and implement functional and technical process and system improvements, while enabling solutions that deliver valued business outcomes for Boston Scientific.

Your Responsibilities will Include:

• Partnering with an IT development team to support the launch and implementation of new system functionality; solicit business requirements, create user stories, and facilitate User Acceptance Testing (UAT)
• Performing qualitative and quantitative data analysis, opportunity assessments, and product experiments
• Analyzing and prioritizing requirements as a part of the overall Product Backlog
• Creating and publishing resources and information for the Post Market Quality organization
• Communicating process changes to users; developing and delivering user training and awareness sessions, as well as other global communications
• Providing support for the Post Market Quality organization to ensure defined quality goals and objectives are met
• Leading and participating in large-scale cross-functional, high-impact projects

Required Qualifications

• Bachelor's degree in any discipline with at least 6 years related work experience
• English Level: B2+: 80-89%
• Medical device quality experience
• Experience with system management, process analysis and development
• Experience with change management
• Proficient with Microsoft Office Suite and SharePoint
• Ability to travel globally, up to 15%

Preferred Qualifications

Note:Work samples will be requested as a part of the hiring process for this role.

• Ability to communicate effectively with individuals on all levels (written and verbally)
• Strong technical acumen with ability to collect, analyze and interpret business information and translate business needs into technical solutions
• Ability to work in a self-directed, fast-paced environment and complete work without significant guidance
• Strong problem-solving capabilities, high sense of urgency, and commitment to execution
• Ability to remain flexible and adaptable to changing needs and priorities
• Experience with Product Teams, Agile Scrum and Kanban methodologies
• Experience with Jira, Salesforce, Power BI or Tableau, SharePoint, Adobe Premiere, and/or Digital Adoption (Whatfix) software