דרושים Manufacturing Engineer Iii ב-Boston Scientific ב-צרפת

Hybrid Roles:

Your responsibilities include:

• Creative and resourceful problem-solving skills for moderate to complex mechanical and electrical devices.
• Ability to assist with troubleshooting, to the component level, moderate to complex mechanical assemblies.
• Implement Value improvement projects for endoscopy products– new suppliers, design changes, etc.
• Working within a team of Sustaining Engineers and (embedded within R&D and Quality Assurance groups).
• Actively contributing to all aspects of Design Quality Assurance activities in an FDA/EUMDR-Regulated Class II Medical Device Software environment including interconnected systems.
• Support the design, development, and test of finished devices and accessories used in Boston Scientific Endoscopy product lines during their entire Development Life Cycle, from the Requirements gathering phase to the End-of-Life phase.
• Participate in product, system, and sub-system level design reviews and design changes with focus on device design evaluation, product risk mitigation, and other required Risk Management activities.
• Support the creation and execution of validation protocols to perform sub-system and system level testing of our products and report any issues discovered.
• Creation and review of risk management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA).
• Creation and review of DQA documentation as required (e.g., Hazard Analysis, Design Failure Modes and Effects Analysis, Design Validation and Usability Engineering related documentation).
• Become a Subject Matter Expert (SME) for design controls and risk management requirements for the products supported.
• Support all aspects of DQA activities during internal and external audits, as needed.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• May perform other duties as directed.

What we’re looking for in you:

• BS in Biomedical, Mechanical Engineering, or equivalent technical discipline.
• English Level desired: C1.
• Minimum of 3 years of medical device engineering experience.
• Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, usability engineering and medical device software.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR part 820, is required, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485 and EN ISO 14971.
• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent).
• Ability to collaborate and work on a global team.
• Travel approximately 10-15% of the time.

Costa Rica-Coyol

Hybrid Roles:

About the role:

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Your Responsibilities Include:

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
• Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
• Assists in generating component specifications.
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
• Analyses incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.
• Reviews new design specifications and provides input from component quality and manufacturability perspective.
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary.

What we're looking for:

• Bachelor or Licenciature degree in Industrial, Materials, Chemistry, Mechanical Engineering and related field.
• Experience: At least 2 years
• English Level desired: 70%.
• Desired knowledge: ASQ certification (CQE, CRE, SSGB, SSBB,CQM) strongly desired, Problem Solving, Knowledge of QSR’s, Networking.

Benefits • Life-Work Integration • Community • Career Growth

Costa Rica-Coyol

About the role:

Evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Assignments have clear and specified objectives and require the investigation of a limited number of variables. Improve existing manufacturing processes and act as liaison between production and engineering group in resolving problems encountered on the production floor. Assist with the introduction of new products into the Operations production area.

Your Responsibilities Include:

• Participates in project teams typically including one of the following: identifying and implementing process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance; designing, performing, and documenting engineering test experiments to evaluate product/product performance; participating in Quality improvement activities; designing, developing, testing, and validating equipment, tools and fixtures; analyzing and interpreting process models and recommending process improvements; evaluates external process technologies; and other activities of limited scope requiring knowledge of principles and techniques commonly employed in the specific narrow area of assignments.
• Participate in equipment and process validation. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
• Participate in equipment and process validation. Write protocols and reports for Equipment Installation Qualification, Operational Qualification and Process Performance Qualification.
• Has working knowledge of Risk Management & Failure mode and effect analysis (FMEA) requirements.
• Interfaces with assemblers, production supervisors, and engineers in troubleshooting problems on the production floor.
• Coordinates with the appropriate suppliers and other external resources needed in developing and implementing process/product improvement plans.
• Acts independently to implement and follow through.
• Perform root cause analysis of failed product.
• Participates in project planning and scheduling.
• Optimize processes for yield improvements, cycle time improvements, and scrap reduction.
• Attends and contributes to product core team meetings.
• Perform responsibilities required by the Quality System and other duties as assigned or requested.

What we're looking for:

• Bachelor or Licenciature degree in Mechanical, Electromechanical, Electronic, Electrical Industrial Maintenance or related.
• Experience: At least 3 years
• English Level desired B2 to C1
• Technical Competencies: Problem Solving, Networking, Process Improvement, Lean manufacturing and Six Sigma knowledge, Process Validations.
• Knowledge of the Lab View programming
• Knowledge of automated vision systems
• This position will work for Shift B: Monday to Friday from 3:30pm to 10pm, Saturdays from 7am to 2:30pm.

Your responsibilities include:

• Contributing to all aspects of Design Quality Assurance activities in an FDA/EU MDR regulated environment.
• Working within a cross functional team of Sustaining Engineers and Specialists such as:R&D, Regulatory Affairs, Marketing, Medical Safety, Manufacturing, Quality, Production and others.
• Supporting the design, development, and test of finished devices and accessories in the Boston Scientific Endoscopy division during their development life cycle, focused on sustaining existing products on the market.
• Provide quality and compliance input to project teams for project decisions and deliverables (i.e Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing and Labeling).
• Participate in product, system, and sub-system level design changes with focus on device design evaluation, design controls, product risk mitigation, and other risk management activities.

• Champion compliance to company policies, work instructions and SOPs.

• Support the creation, review and maintaining of risk management documentation such as: Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA), Fault Tree Analysis (FTA) and Usability Engineering documentation.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e 5 Whys Analysis, Is-Is Not Analysis, Cause and Effect Analysis and DMAIC problem solving methodologies).
• Participating in Value Improvement Projects (VIPs), cost reduction initiatives such as: new suppliers, alternate materials, design changes, etc.
• Support DQA activities during internal and external audits, as needed.
• May perform other duties as directed

What we’re looking for in you:
Minimum Qualifications

• BS in Biomedical, Mechanical Engineering, or related technical discipline.
• Minimum of 2yearsof medical device or related engineering experience.
• Strong communication and presentation skills.
• Problem solving and critical thinking skills.
• Competent with use of Microsoft Office Suite andMinitab statistical analysis software (or equivalent).
• Ability to collaborate and work in a global team.
• Position located in Coyol, Costa Rica.
• Willing / able to travel approximately <10% of the time.

Preferred Qualifications

• 2+ years of medical device engineering.
• Knowledge of medical device risk controls / risk management.
• Familiar with FDA QSR, EN ISO 13485, EN ISO 14971, and IEC 60601 regulations and standards.

About the role:

This role will be responsible for leading the change enablement strategy and execution across the project workstreams, beginning with Workstream 3 (Documentation, Rework, and Nonconformance). This includes stakeholder engagement, communication and adoption strategy, change readiness, and alignment of key roles and responsibilities at the global and site level.

Your responsibilities will include:

• Lead the overall change enablement strategy for the project, coordinating across all workstreams and site locations
• Partner with program leadership and sponsors to align change strategy with program milestones, CAPA priorities, and quality system improvements
• Drive executive-level sponsorship engagement, including development of sponsor plans, visibility strategies, and stakeholder alignment tactics
• Conduct enterprise-level stakeholder and impact assessments, change readiness reviews, and role adoption plans across business functions
• Design and lead facilitation of global bootcamps, adoption workshops, and functional alignment sessions to accelerate ownership and adoption
• Oversee creation of communications, personas, “What’s Changing” materials, and change roadmaps tailored for multi-audience engagement
• Define, monitor, and report on adoption and change effectiveness metrics at both the program and site levels
• Coach Workstream PMs, Site Coordinators, and functional leaders on leading through change using ADKAR and CLARC frameworks
• Serve as a strategic liaison between the Change Enablement team and the project to ensure consistency, alignment, and scalability of tools and methods
• Represent the OCE team in leadership forums, governance meetings, and enterprise change planning efforts beyond the project

Required Qualifications:

• Bachelor’s degree in Organizational Development, Communications, Psychology, or related field (or equivalent experience)
• 8+ years of experience in change management, enterprise transformation, or regulatory remediation initiatives
• Demonstrated leadership in planning and executing complex, cross-functional change programs
• Experience building and executing leadership engagement, site readiness, and adoption strategies in a regulated industry
• Advanced knowledge of structured change methodologies (e.g., Prosci ADKAR, Kotter, McKinsey Influence Model)
• Strategic thinker with a proven ability to lead enterprise-level change initiatives
• Strong executive presence and ability to influence across levels and functions
• Expert in translating technical projects into people-centered adoption strategies
• Outstanding communication, facilitation, and stakeholder engagement skills
• Skilled in change metrics, readiness assessments, and adoption risk mitigation
• Able to operate in a fast-paced, regulated environment with shifting priorities
• Strategic thinker with a proven ability to lead enterprise-level change initiatives
• Strong executive presence and ability to influence across levels and functions
• Expert in translating technical projects into people-centered adoption strategies
• Outstanding communication, facilitation, and stakeholder engagement skills
• Skilled in change metrics, readiness assessments, and adoption risk mitigation
• Able to operate in a fast-paced, regulated environment with shifting priorities

Preferred Qualifications

• Master’s degree in I/O Psychology, Organizational Leadership, or related field
• 10+ years of experience leading change across global, matrixed organizations
• PROSCI Certification and/or ACMP Certification
• Experience leading change within quality, regulatory, or compliance-driven transformation programs

• Experience reporting to senior leadership or sponsors on adoption progress and change risk mitigation
• Experience designing and scaling change frameworks across multiple workstreams and business units
• Deep facilitation skills—bootcamps, executive alignment sessions, and adoption planning workshops

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:

Develop, implement, maintain, and improve appropriate quality system elements to ensure the high-quality level of new and existing products. Provide support to internal and external audits (including unannounced audits/inspections), internal/external audit findings, and Case for Quality annual appraisals. Provide support to Quality Planning to ensure flawless execution of the subprocess, providing tracking and follow-up for timely closure of site QPTPs/QSPD as required to avoid impact to metrics. Also, will support Open Loops forum to help gather information and track timely resolution of red metrics. Overall support to other Quality Systems subprocesses for the site will be provided by this role. Provide guidance and support for other day-to-day activities within the department. Serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities.

Your responsibilities include:

• Execute and support internal and external audit activities, as well as lead internal audits.
• Monitor and track the progress of internal audits tasks and initiatives. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines.
• Monitor and track site metrics related to internal and external audits, contribute to Quarterly Management Review (QMR) meeting deliverables and follow up on action items.
• Collaborate with NCEP and CAPA owners on documentation, timelines, and eCAPA system use, to prioritize tasks and ensure content is clear/well-documented, especially when related to internal/external audits.
• Apply sound, systematic problem-solving methodologies to support teams in identifying, prioritizing, communicating, and resolving quality issues.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Create, revise, and approve departmental procedures and quality system records.

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)

Preferred Requirements:

• Experience with internal and external audits.
• Project/task management experience
• Experience with Product Lifecycle Management systems (i.e. Windchill, PLM)
• Experience with nonconformance and/or CAPA process
• Experience with AI tools (MS Copilot, ChatGPT) and/or data management dashboards (Power BI, Tableau)

Númerode la requisición:609079

Como líder en ciencia médica durante más de 40 años, estamos comprometidos a resolver los desafíos que más importan, unidos por un profundo cuidado por la vida humana. Nuestra misión de promover la ciencia de por vida consiste en transformar vidas a través de soluciones médicas innovadoras que mejoran la vida de los pacientes, crean valor para nuestros clientes y apoyan a nuestros empleados y las comunidades en las que operamos. Ahora más que nunca, tenemos la responsabilidad de aplicar esos valores a todo lo que hacemos, como empresa global y como ciudadano corporativo global.

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 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.
• Demonstrates PDP/TPD system knowledge through delivery of high quality and high impact deliverables.
• 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're looking for:

• Bachelor or Licenciature degree in Mechanical, Electromechanical, Electronic, Mechatronic, Electrical Industrial Maintenance or related field.
• Experience: At least 2 years
• English Level desired: 85%.
• Basic Knowledge in processes and manufacturing of medical devices
• Basic knowledge on problem solving techniques.
• Ideal knowledge in Design Controls