דרושים Supplier Qa Engineer ב-Boston Scientific ב-El Salvador, Lourdes

Your Responsibilities Include:

Demand Planning

• Lead SI&OP process for the business and drive the decision-making process.

• Coordinate base & high-side forecasting plans related to the Franchise products.

• Manage and provide work direction to Global Supply Chain Planners

• Review statistically generated forecasts with Marketing and Finance and drive for consensus forecast creation.

• Review Safety stock targets and approve changes, noting input elements resulting in change.

• Work with Global Marketing, Country Demand Planning, and Country Operations groups to identify all known demand sources (customer orders, scheduling agreements, distributor shipment, consignment, etc.)

New Product Launch Management

• Core Team Member for Supply Chain on New Product Development Team

• Develop launch plans, including forecasts, inventory targets, cannibalization plans, and introduction schedules with support of stakeholders.

• Lead Launch Adherence meeting cadence & coordination, execute launch workbooks and prepare distribution chain for product launch.

• Provide leadership on coordination of supply activities during product launch execution.

Inventory Management

• Lead the development of inventory plans including inventory reduction projects.

• Diagnose excesses to inventory objectives and develop plan to remediate; calculate and report on EE&O

• Lead process for divisional managing and reporting of component Last Time Buy and Finished Good inventory buffer activities for regulatory or other events.

• Effectively drive inventory management between version changes, UPN run-outs, and geographic-specific buffers.

Supply Chain Execution

• Function as key member of the Franchise Leadership Team responsible for service level, inventory levels, and overall coordination of supply chain

• Achieve KPI Metrics: Service Level/Backorder; Inventory; Forecast Accuracy/Bias; Healthy Stock and Inventory charges.

• Drive execution of end-to-end supply chain by supporting the planning processes utilizing Rapid Response (Advanced Planning System)

• Diagnose service level failures, develop mitigation plans, and implement corrective actions to prevent recurrence.

Management Requirements

• Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

• Will lead a team of employees in the achievement of organizational goals; guide, coach, direct, and develop direct reports.

• Monitor and ensure compliance with company policies and procedures (e.g., federal/country, and regulatory requirements)

Required Qualifications:

• Four-year degree in Engineering/Supply Chain Management and related field/equivalent work experience

• 7+ years’ experience in supply chain planning, materials management, manufacturing planning or inventory control function.

• Demonstrated ability to lead, coach, train, or mentor others.

• Effective communication skills with the ability to successfully interact and influence at all levels of the organization both domestically and internationally.

• Ability to take initiative and lead projects independently with a strategic mindset

• Consistently performs to a high level of accuracy in all tasks, high level of attention to detail.

• Adaptable, flexible, and willing to accept new ideas, processes, and procedures.

• Analytical critical thinking skills and able to make efficient decisions.

Preferred Qualifications:

• Experience utilizing SAP or other ERP systems.

• Experience utilizing Rapid Response or other Advance Planning Systems

• Experience in a manufacturing environment
• Continuous improvement experience including Six Sigma, Lean Manufacturing
• MBA or Master’s Degree in Supply Chain Management or related field
  

Maximum Salary: $ 197000

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.

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.

The anticipated annualized base amount or range for this full time position will be, plus 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.

Hybrid Roles:

About the role:

Seeking a skilled System Verification Engineer to join the Boston Scientific Neuromodulation R&D team. As a key member of the team, you will play a crucial role in ensuring the reliability and performance of our neuromodulation systems through rigorous verification processes. You will work closely with cross-functional teams to verify features and system functionality against design requirements. Your expertise will contribute to the development and execution of comprehensive system level design verification strategies, while collaborating with stakeholders to define design requirements and test methodologies.

This is a Hybrid role, located in Heredia and will require 3 days per week in the office.

Responsibilities:

• Conduct verification of implantable and external Neuromodulation Product Systems with a focus on hardware/software integrated systems.
• Develop and execute verification plans, protocols, and test cases to ensure product compliance with design specifications and regulatory requirements.
• Collaborate with cross-functional teams, including hardware, software, and system-level testing, to support verification activities.
• Assist in the development and support of verification tools, test environments, and automated test systems.
• Help create, establish, and document verification processes and methodologies, and provide support for validation and verification activities.
• Ensure that verification strategies cover detailed verification design requirements effectively.
• Identify technical risks and assist in developing risk mitigation plans. Implement phased verification approaches to mitigate risk and support the creation of documentation as part of the Product Development Process (PDP) and Quality Management System.

Minimum Requirements

• Bachelor’s degree or more from an accredited school in Electrical Engineering, Computer Engineering, Electromechanical Engineering, Systems Engineering, Computer Science, or related field.
• 2+ Years of work experience in engineering with a Bachelor’s degree.
• Ability to understand, properly interpret, and evaluate whether a design requirement is properly written.
• Proficiency in using automated testing frameworks is essential for efficiently conducting verification tests and ensuring the reliability and performance of the systems.
• Experience with version control systems (e.g., Git), Dev Ops and CICD methodologies.
• Knowledge of programming and scripting languages such as Python, C++, LabView, and Matlab for developing and executing verification tests, as well as for automating various aspects of the verification process.
• Fluency in using EE test equipment like oscilloscopes, function generators, and data acquisition (DAQ) equipment.
• Excellent written and verbal communication skills.
• English advanced

Preferred qualifications

• Understanding of hardware-software integration.
• Up to 1 year of work experience in Systems Verification.
• Experience working with complex HW systems, ideally implantable or capital medical products..
• Up to 1 year of experience designing verification strategies for systems-, sub-systems, system interfaces, and integration.
• Experience in with system characterizations and trade-offs analyses (Ex. power budgets, data storage/transmission, battery selection, BLE antenna designs, lead/electrode designs for various use cases).
• Experience with software products both as a Medical Device (SaMD) and in a Medical Device (SiMD).
• Experience with Data Privacy and Cybersecurity for connected medical product systems.
• Experience collaborating with hardware, mechanical, electrical, algorithms, and software teams.
• Experience in algorithm and firmware development and product implementation.
• Experience with hardware-cloud-app systems.
• Experience in the medical device, aerospace, electronics, or other advanced technology and/or regulated industries.
• Experience with advanced statistics, including T-Test, ANOVA, Gage R&R, Design of Experiments (DOEs), etc.

Costa Rica-Heredia

Hybrid Roles:

About the role:

Develops new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials. Ensures solutions meet performance, quality, and regulatory requirements while supporting long-term product sustainability and reliability.

Your Responsibilities Include:

• Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment.
• Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Selects techniques to solve complex problems and make sound design recommendations.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Designs and prepares complex reports to communicate results to technical community.
• Designs and coordinates complex engineering tests and experiments.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
• Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices.
• 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 and/or provide work direction to technicians and entry-level engineers.
• Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
• Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.

What we are looking for:

• Bachelor’s/Licenciature Degree: Chemical Engineering, Chemistry, Mechatronics, Mechanical, Materials Science or Biomedical engineering.
• English level: +90%.
• Experience: +7 years in related positions.
• Desired knowledge: Design Controls, Desig validation and Verification plans protocol and report generation, Risk Management, Minitab.

Benefits • Life-Work Integration • Community • Career Growth

Francisco Munoz Munoz

Your responsibilities include:

• Provide technical knowledge to innovate, develop and/or support processes, procedures, tooling and/or automation in the manufacturing process.

• Create and understand documentation as it relates to technical discipline (e.g., specifications, validations, prototypes, technical manuals, 3D Models/schematics/equipment drawings/BOM’s).

• Lead problem solving teams using BSC Engineering Essentials Tools.

• Apply Project Management Tools to effectively ensure that Equipment Projects meet overall performance, schedule and cost requirements.

• Demonstrate an ability to manage multiple complex projects.

• Understand how equipment projects positively impact the elements of product cost.

• Actively participates in cross-functional business improvement opportunities.

• Communicate frequently and effectively with Equipment Project sponsors, clients and stakeholders.

• Provide Technical Knowledge for Relocation, Installation, Start-up, Qualification, Training and Sustaining of Equipment related to Product / Process Transfers across BSC Manufacturing Network.

• According to the nature of the business, the person in this position may execute a supervision role, where he/she will oversee for the success of equipment maintenance indicators under his/her scope (down time, customer service, wait tech, failure root cause, spare part consumption, tools inventory, 5s audit score, etc.). Also may ensure the execution and success of preventive maintenance audits performed on Production Area equipment and the complete adherence to regulatory aspects for CMs-PMs.

• In parallel, the person on this position may execute a supervision role, in order to ensure the success of the following activities: oversee the group of technicians assigned and their development(under an environment of respect, accountability and team work), ensure the technicians assigned follow the expectations defined by BSC, contribute to the continuous improvement efforts of the dept., adequate use of PPE/LOTO, coordinate maintenance activities during Shut Downs, execute disciplinary actions as required, process punch marks at Kronos and ensure the correct behaviors related to follow the schedule defined.

What we are Looking For:

• Bachelor's degree or above in Engineering or related field
• 6-8 years of experience
• Desire Experience in the Medical Device Industry
• C1+ English Level
• Expertise en Excel
• Experience in Equipment, preferably in Medical devices
• Knowledge in vision systems for Quality Control, Lab View (desirable).
• Reporting to high levels.
• A team player.
• Experience in managerial roles.

Benefits • Life-Work Integration • Community • Career Growth

Francisco Munoz Munoz

Your Responsibilities Include:

• Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined packages, products, processes, or equipment.
• Responsible for coordination of all product labeling deliverables with minimum supervision, including labels, IFUs, carton and pouch artwork, etc.
• Fully participates and successfully contributes to project teams through the completion of complex engineering/packaging work in one or more of the following: packaging design and development, packaging testing, preparation of specifications, test/engineering reports preparation.
• Leads project teams of moderate to large scope through the definition of goals and objectives, project planning, execution of activities, and project follow-up.
• Works independently to plan and schedule own activities necessary to meet timelines.
• Demonstrates proficient Sustaining Engineering knowledge through completion of high-quality deliverables.
• Coordinates, creates, and enhances packaging components for Sustaining Engineering based on pre-existing formats and design, and in accordance with regulatory, quality, and business requirements. As applicable, executes these actions for new product/packaging development.
• Performs Change Notice activities for the review, approval and release of packaging components and documentation.
• Designs, coordinates, and executes complex engineering tests and experiments for existing product/packaging design improvements and, as applicable, new product/packaging development. Compiles and analyzes data. Draws conclusions from results.
• Generates and reviews complex packaging-related documentation, including specifications, test plans, reports, and other documents.
• Interfaces with Physicians/Lab personnel to obtain feedback on concepts and performance of new devices or packages.
• Translates customer needs into product requirements and design specifications.
• Works cooperatively with various Boston Scientific departments, divisions, and suppliers, to ensure an improved, practical, and consistent approach to packaging.
• Performs troubleshooting on new problems as related to design, material, or process. Selects techniques to solve complex problems and make sound design recommendations.
• As applicable, provides work direction to technicians and other employees on packaging processes or test procedures.
• Serves as a resource in the orientation and training of new engineers and employees.
• Identifies areas for improvement, suggests solutions, and submits idea records.

What we're looking for:

• Bachelor or Licentiate degree in Engineering (Industrial, Design, Chemical/Materials, Mechanical) or related field.
• English Level desired: C1 or above.
• A minimum of 5 years of experience in Packaging Engineering is desired.
• A minimum of 5 years of experience in Medical Devices Industry is desired.

• Or an equivalent combination of education and experience.

Costa Rica-Heredia

Hybrid Roles:

About the role

We are seeking a highly experienced Senior System Verification Engineer to join the Boston Scientific Neuromodulation R&D team. As a key member of the team, you will play a critical role in ensuring the reliability and performance of our neuromodulation systems through rigorous verification processes. You will work closely with cross-functional teams to verify features and system functionality against design requirements. Your expertise will drive the development and execution of comprehensive system level verification strategies, while collaborating with stakeholders to define design requirements and test methodologies.

This is a Hybrid role, located in Heredia and will require 3 days per week in the office.

Lead System Design Verification:

• Lead the verification of implantable and external Neuromodulation Product Systems with a focus on hardware/software integrated systems.
• Develop and implement verification plans, protocols, and test cases to ensure product compliance with design specifications and regulatory requirements.

Provide Technical Leadership:

• Provide technical leadership on cross-functional verification efforts, including hardware, software, and system-level testing. Act as an R&D representative on cross-functional deliverables, ensuring alignment with verification objectives.

Collaborate with Stakeholders:

• Collaborate with stakeholders outside R&D to understand current and future market needs and incorporate these inputs into verification strategies. Translate high-level customer, business, and manufacturing needs into detailed verification requirements.

Develop and Support Verification Tools and Processes:

• Ensure effective development and support of verification tools, test environments, and automated test systems.
• Create, establish, and document verification processes and methodologies.
• Provide expertise and guidance for validation and verification activities.

Risk Management and Project Planning:

• Identify technical risks, develop risk mitigation plans, and implement phased verification approaches to mitigate risk.
• Act as a Technical Project Manager within the Systems Engineering function on assigned programs, performing detailed project planning, resource and budget planning, tracking, dependency and issue identification, and reporting.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

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.

Education and Work Experience:

• Bachelor’s degree or more from an accredited school in Electrical Engineering, Computer Engineering, Electromechanical Engineering, Systems Engineering, Computer Science, or related field.
• 5+ Years of work experience in engineering with a Bachelor’s degree.

Experience in a Regulated Environment:

• 2+ years of work experience in a regulated environment, preferably in the Medical Industry.

Translating High-Level Needs into Detailed Requirements:

• Experience translating ambiguous and high-level customer, end user, business, and manufacturing needs/requirements into detailed verification/test objectives, protocols & scripts.
• Ensure that the verification process aligns with the overall goals and needs of the stakeholders.

Designing Verification Strategies:

• 2+ years of experience designing verification strategies for system-of-systems architecture, system interfaces, and integration.
• Develop comprehensive verification plans that address the complexities of integrated systems.

Advanced Statistical Analysis:

• Strong experience with advanced statistics, including T-Test, ANOVA, Gage R&R, Design of Experiments (DOEs), Response Surface analysis, probability, 6 Sigma, etc.

Technical Leadership and Stakeholder Alignment:

• 2+ years of experience in creating and aligning stakeholders to a vision, strategy, and designs for verification efforts that span multiple products.
• Lead cross-functional teams and ensuring that verification strategies are aligned with business and technical goals.
• Experience with automated testing frameworks.
• Knowledge of programming/scripting languages such as Python, C++, LabView, Matlab.
• Solid understanding of EE concepts (Ohms law, DSP, analog / digital electronics)
• Ability to Architect Test Environments and experience with version control systems (e.g., Git), Dev Ops and CICD methodologies.
• Understanding of hardware-software integration.
• Fluent on the use of EE test equipment like oscilloscope, function generators, DAQ equipment.

Desired Requirements:

• 1+ years of direct experience working in the Technology Development (TDP) and Product Development (PDP) phases of the product lifecycle.
• Experience working with medical device microprocessors, ASIC, or SOC (system on chip) system architecture.
• Experience participating in system characterizations and trade-offs analyses for power budgets, data storage/transmission, battery selection, BLE antenna designs, lead/electrode designs for various use cases.
• Experience delivering software products both as a Medical Device (SaMD) and in a Medical Device (SiMD).
• Experience with Data Privacy and Cybersecurity for connected medical product systems.
• Experience participating in integration and overseeing collaboration among hardware, mechanical, electrical, algorithms, and software teams.
• Experience in algorithm and firmware development and product implementation.
• Experience leading R&D team failure analysis investigations, root cause identification, and driving process/product improvements.