דרושים Supervisor Team Lead 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.

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.

About the Role:
The Senior Facilities Supervisor is responsible

Responsibilities include:

• Coordinate with the technical team to ensure continuity of production and plant operations by efficiently supervising resources, controlling environmental conditions in production rooms, and managing external requests.
• Maintain up-to-date knowledge of the operational status of facilities equipment (mechanical, electrical, electromechanical, electronic), and manage digital systems (BMS, maintenance, documentation, task/ticket management). Apply efficiency tools for problem analysis and resolution.
• Establish and develop operational goals for both the technical staff and personal development, aligned with organizational objectives.
• Foster talent development within the technical team through individual development plans, technical coverage and succession planning, promoting responsible and progressive training.
• Manage and supervise contractors assigned to operational activities, ensuring compliance with established standards and deadlines.
• Collaborate on the implementation of technical improvements to facilities equipment, aiming to optimize operations and ensure proper functionality.
• Ensure an adequate supply of spare parts for all equipment, as part of technical staff expectations, minimizing downtime.
• Provide efficient support to facilities projects by appropriately allocating technical resources to ensure successful execution.
• Monitor performance indicators related to systems and building operations, implementing corrective actions when necessary.
• Lead daily tactical meetings between engineering operations and the technical team, facilitating communication and issue resolution.
• Supervise the budget assigned to technical personnel for facilities systems improvements and operations, ensuring proper execution and control.
• Lead the induction and technical development program for new company personnel, ensuring effective integration aligned with organizational standards.
• Lead facilities operations during plant shutdown periods, coordinating activities and resources to minimize production impacts.
• Manage corrective and preventive work orders, efficiently assigning technical resources and ensuring timely execution.
• Support continuous improvement processes and problem-solving related to facilities operations by implementing corrective and preventive actions.
• Understand and apply regulations for ISO 8 controlled rooms, ensuring compliance with specific environmental conditions.
• Monitor and improve the organizational climate of the technical team, promoting a positive and productive work environment.

Requirements:

• Bachelor’s degree in Industrial maintenance engineering, Electromechanics, Mechanics, or Electrical Engineering (mandatory).
• English proficiency 80% (Intermediate–Advanced level).
• At least 5 years of experience as a Facilities Technical Supervisor managing technical resources, preferably in the medical industry.
• Required knowledge: Facility systems such as but not limited to HVAC, industrial electricity, mechanics, electromechanics or related fields (mandatory).
• Availability to work an administrative shift from Monday to Friday, with occasional weekend requirements due to 24/7 responsibility over technical staff.

Preferred Technical Qualifications:

• Knowledge of facility systems in general industry, preferably medical.
• Proven knowledge in industrial and comfort HVAC systems, chilled water systems, low, medium, and high-voltage electrical systems, ISO 8 room validation or re-certification, fire detection and suppression systems, oil-free compressed air systems, BMS and CMS management, and production environmental controls.
• Budget management for preventive and corrective maintenance, improvements, or spare parts. Experience with contractor oversight for job execution.
• Knowledge of environmental, occupational safety, energy, and quality requirements.
• Knowledge in maintenance control systems, asset management, predictive systems, and problem-solving.

608550

Recruiter:Edward Torres Fonseca

Hybrid Roles:

About the role:

Directly responsible for the production, as well as line personnel.

Your Responsibilities Include:

· Oversee operations efficiency and standardization.

· Directly responsible for the production and quality of the product, as well as 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.

· 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.

· Provide feedback to PB IV.

What we're looking for:

· Bachelor degree in Business Administration, Industrial Engineering or Field Related.

· Experience: At least 5 years

· English Level desired: 80%.

· Desired knowledge: Problem Solving, Methodologies; Lean Tools: 5S, CQE y/o APICs Certification desirable.

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 Information System Engineering
• English Level: B2 (70% -79%).
• Desired knowledge: CQE y/o APICs Certification desirable, Problem Solving methodologies, Methodologies; Lean Tools: 5S, CQE y/o APICs Certification desirable

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.