דרושים Hr Operations Sr Manager Heredia ב-Boston Scientific ב-Costa Rica, Heredia

Costa Rica-Heredia

Hybrid Roles:

Your responsibilities include:

Designs, develops, debugs, modifies, and tests electrical, software and imaging design solutions by using current tools, analysis techniques, and technologies.

Investigates, researches, and selects electronic circuits, components, tools, equipment using best practices.

Provides project support and executes activities to ensure the safety, quality, and compliance for the design of products while continuously improving their commercial value through end of life.

Partners with technical leaders to solve technical problems using theoretical analysis, experimentation, and problem-solving methodologies to make data-based design decisions.

Coordinates with internal functions and external suppliers to identify and execute projects to deliver high quality engineering solutions at an accelerated pace.

Ensures products are compliant to electrical safety standards and other regulatory requirements.

Supports design of standard engineering tests and experiments.

Performs troubleshooting on products and manufacturing processes as related to design, material, or process.

Summarizes, analyzes, and draws conclusions from test results.

Documents product development by writing reports, memos and change requests. Methods used are determined by approved procedures and standards.

Tracks product development effort by creating and maintaining records in the approved tracking management tool.

Supports design transfer activities between Product Development and Sustaining Engineering

What we are looking for:

• 2+ years related experience; Experience in a regulated medical device environment preferred.
• Degree in Electrical Engineering, Mechatronics,Biomedical Engineering, or other related field (computer, systems). Bachelor’s or above required.
• Effective communications/presentation skills to all levels of the organization (both written and verbal)
• Experience in all areas of responsibility is not required. A strong aptitude and willingness to learn is required.
• Less than 10% travel.
• Preferred English Level: 80-89% +
• Please submit Resume in English.

Costa Rica-Heredia

Hybrid Roles:

Key Responsibilities

• Supervise the HRSD Support team (to be organized by country/language).
• Act as a team leader: ensure onboarding activities, presence, availability, access rights, tools, etc.
• Participate in the development of a Service Delivery cross-training plan and ensure team members become appropriately trained.
• Escalation points for support team to resolve complex issues.

• Monitor tickets, activities & performance of the team daily.
• Ensure strong quality as well as productivity standards & accountability within the team.
• Coach team members to drive improvements and service standards.
• Build strong relationships with key customers & partners (HR Service Center (HRSC), Employees & HR community) to meet end-user expectations.
• Partner with the HRSC and LATAM HR Team to the tiered governance structure.
• Execute continuous improvement activities across HRSD Support Team and support HR Center of Excellence (CoEs) to improve core HR processes.
• Support Service delivery analysts in issue resolution by providing information on root-cause analysis and execute intervention plans to address issues systemically. Act as point of escalation for any issue resolutions with HR services provided.
• Participate in and represent LATAM region in regular HR Service Delivery activity/performance review meetings.
• Ensure work is supported by appropriate documentation which is reviewed, updated, and maintained on a routine basis.
• Partner with Regional Process Lead to ensure appropriate processes are in place.
• Support optimization and updates to HR processes (methods & procedures) working with the HRSC.
• Track Service Level Agreements (SLAs) and measure achievement against team/individual performance criteria.
• Monitor cases to ensure quality and consistency across LATAM by providing feedback and coaching HR Service Delivery Support team where necessary.
• Ensure services are delivered in compliance with corporate policies and procedures or any other federal / country regulation as requirements.
• Ensure that the HR Service Delivery Support team prioritizes activities in accordance with SLAs/Key Performance Indicators (KPIs).
• Oversee the dispatching of cases within the HRSD Support team.
• Monitor the volume of cases and activities against available resources.
• Escalate and solve difficult cases and manage customer relationships where necessary.
• Lead, develop and coach Support the team in their professional development needs by ensuring they receive ongoing regular feedback, training and help in identifying, supporting and achieving agreed development objectives.

Qualifications:

• Bachelor’s degree in Human Resources, Business Administration or related field.
• At least 5+ years of experience preferably in Talent Acquisition, Total Rewards, Benefits administration, HR Shared Services.
• Experience managing and coaching a team.
• Language skills required English level C1 and Portuguese highly desired.
• Strong communication and writing skills in English and desirable in Portuguese.
• Experience with Workforce and case management systems, preferred experience with SuccessFactors and ServiceNow.
• Experienced in MS Office Applications (Excel, Word, PowerPoint).
• Analytical & problem-solving skills.
• Please submit resume in English.

Additional Qualifications & Competencies:

• Customer service orientation: ability to provide excellent support and service to internal and external clients
• Attention to detail: Ensuring accuracy and thoroughness in all tasks
• Team Collaboration: Ability to work effectively within a team and across departments
• Adaptability: Flexibility to handle changing priorities and workloads
• Leadership skills: ensure and assist the team to achieve business goals.

Internal candidates requirements:

• A year in the current position, in the company.
• Performance Evaluation: Successful or above
• Don't have disciplinary actions in the last 6 months.

Hybrid Roles:

Key responsibilities include:

• Leads quality team in sustaining activities to support commercial product monitoring on projects of major magnitude and scope. Key Quality voice of influence on projects.
• Leads quality team on functional deliverables and ensures technical excellence for product or technical development.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP.
• Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Maintains and enhances cross-functional team relationships.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.

What we're looking for in you:

Required Qualifications:

• Minimum of a Bachelor's degree
• Minimum of 7 years of related work experience or an equivalent combination of education and work experience
• Proven technical leadership and project management skills in medical device design, development, and commercialization
• Proven independent critical thinker, strong communication skills, strong presentation skills, and ability to build effective cross-functional relationships
• Ability to interface with customers to gather insight and get organizational buy-in on key design inputs
• Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations
• Medical Device or regulated industry experience

Preferred qualifications:

• Bachelor in an engineering discipline
• Advanced degree in technical field or business.
• Experience leading technical teams.
• Experience with Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
• Familiarity with BSC products and customer needs

Costa Rica-Heredia

About the role:

• The Principal Project Manager role will play an integral part in leading Sustaining/product integration projects within the Peripheral Interventional (PI) and/or Interventional Cardiology (IC) Division. Scope of projects includes all product support activities from initial launch to product end of life across PI business units and manufacturing sites. Project size ranges from small one-off tasks to large process improvement, design change, design transfers, line extension and projects/Corporate initiatives driving global productivity.
• Work directly with supporting cross-functions across business units and manufacturing sites. Cross-functional teams include, but not limited to, Research & Development, Design Assurance, Packaging, Regulatory, Process Development, Operations, Supplier Engineering/Quality, Supply Chain and Clinical.

Project/Program Management:

• Develops and implements overall project plan, including cost, schedule, risk and performance and monitors progress against business key objectives and goals.
• Identify prioritization and resource needs for assigned projects and activities with supporting cross-functions.
• Identify, communicate and manage technical challenges and business risks.
• Drive and influence results by acting with speed, agility and adaptability, assigning clear authority and accountability while integrating and aligning efforts across manufacturing sites and cross-functions.

• Provides structured thinking to project team on overall approach and delegates as appropriate.
• Directs and trains key project management processes.
• Leads the team in appropriate decision making through strong influence and the ability to analyze options and implications.
• Investigate and develop approach/solution to address technical problems with project teams.
• Direct control over activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.

• Foster a diverse workplace that enables all team members to contribute to their full potential in pursuit of organizational objectives.

• Provide timely communication on project progress updates to all relevant cross-functions and levels within the organization, including presentations to senior leadership.

Communication:

• Responsible for team and cross-functional level communications.
• Responsible for elevating critical business decisions to the appropriate management boards and/or functional managers.
• Liaison between the team and the Business Planning Team/Franchise Leadership Team (BPT/FLT), as required.

Relationship/People Management:

• Lead, coach and help diverse and dispersed project team members to execute towards overall project goal(s).
• Provides input to cross-functional Managers/Directors on team and team member performance.
• Develops and maintains strong relationships with functional heads to drive success of project team members and overall team member contributions.
• Ability to develop cohesive and collaborative cross-functional teams throughout project lifecycle phases.

Product/Compliance Management:

• Directs and/or provides input to the technical approach on product design and process changes.
• Directs and/or provides input on compliance update/changes on processes and/or systems.
• Identifies, communicates, and manages project risk.
• Monitor and ensures compliance with company policies and procedures (i.e. federal/country and regulatory requirements).

Process Management:

• Product lifecycle process knowledge to deliver and to maintain high quality and high impact deliverables.
• Knowledge of quality system use for the creation and continued compliance of products.
• Actively reviews policy and practice improvements to drive functional excellence.
• Influences cross-functional systems effectiveness.
• Financial management, including budget, forecast, and strategic plan input and preparation.

Key Leadership Competencies

• Strategic Thinking
• Communication
• Planning
• Influence

What we’re looking for:

Minimum Qualifications

• Bachelor’s degree required, preferably in Engineering or Project Management.
• More than 8 years of relevant experience, preferably within medical device industry.
• Small and large cross-functional project team lead experience.
• Must be willing and able to travel internationally ~10% of the time.
• Works under minimal supervision.

Preferred Qualifications

• PMP certification.
• Previous Sustaining and/or product integration experience and/or knowledge.
• Demonstrated ability to lead and work together with a cross-functional, multi-site sites.
• Strong organization, execution and communication skills.
• Candidate to be comfortable in front of all levels of the organization as well as external customers.
• Candidate to have strong leadership and interpersonal skills and ability to build relationships within project teams.
• Problem solving technical expertise.

About the Role:

Leads initiatives for the daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).

Your Responsibilities Include:

• May execute the following resposibilities:
• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
• Consistently generates innovative and unique solutions to meet department goals.
• Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
• Selects process improvement techniques to solve complex problems and make sound equipment and process recommendations.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Designs and prepares complex reports and communicates results to the 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.
• Completes and manages complex Capital Equipment Request Authorizations (CERA’s).
• Leads cross-functional project teams.

What We’re Looking For:

• Licenciature in Mechanical, Electromechanical, Electronic, Biomedical, Chemistry, Industrial'Electrical Industrial Maintenance. Master Degree is a plus
• English Level: B2+(80% - 89%).
• Desired knowledge: Process Manufacturing certification, Problem Solving, Regulatory Industry management, Regulatory affair, Networking, Process Validations, Statistical and Experimental Analysis, DOE, Solid Works, Tranfer Process, Minitab, Hands & Statistics, Tools (Statistics, Technical Manuals, Kaizen, Six Sigma)

Costa Rica-Heredia

Hybrid Roles:

Your responsibilities include:

• Project/Program Management: Manages key initiating, planning, executing, controlling, and closing processes; develops and implements project plan; builds team ownership and commitment to project plan. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort. Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project. Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans. Identifies and manages project dependencies and critical path items while ensuring project quality and utilizing and following appropriate methodologies (e.g. PLCP). Assures project quality by using standard development methodologies. o Communicates project status by preparing standard status reports, and by participating in project status update meetings. Resolves project issues by working with team members, project customers, and others as appropriate. Consults with internal project groups by sharing project management knowledge. Conducts project post mortems and communicates lessons learned in order to identify successful and unsuccessful project elements. Participates in external project management organizations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.
• Led cross-functional, multi-dimensional product development teams from concept through Launch; through proper execution of design controls that include an efficient transfer of newly developed products from Global R&D to manufacturing and global marketing through the BSC-defined PDLC processes to achieve project closure.
• Acts as liaison with other functions/sties for projects site is a contributor or stakeholder in.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.

What We’re Looking For:

• Licenciature degree or above in Mechanical Engineering, Electrical Engineering or Field Related.
• English Level required: C2:(95-100%).
• Desired knowledge: Risk Management/ Risk Mitigation, Program Management, External Regulations (p.e. Quality, Systems) Master Degree in PM or equivalent, PMI certified PM.
• At least 10 years of experience in similar position.
• Please submit Resume in English\

Costa Rica-Heredia

Hybrid Roles:

About the role

Responsible for test development strategy and requirements. Plan and schedule the entire test development process. Define, design & oversee the manufacturing, fabrication, assembly, checkout, support, and validation of special automated test equipment. This includes scheduling, resource allocating, interfacing with cross functional team, writing test requirements, test specs, test software, test procedures, validation plans and reports. Scope of equipment - R&D verification and validation and production test equipment for both new product development and existing product sustaining.

Your responsibilities include:

• Interface with Digital Hardware, Analog Hardware, and Software Design Engineers to define test strategy and critical performance parameters for testing different levels of product assembly (i.e. PCBA, device level).
• Work with R&D engineers to design testability into new products.
• Work in conjunction with design engineers, manufacturing engineers and quality engineers to write test requirements, test specifications & test procedures.
• Be an ATE functional representative in the product design team.
• Generate related documents such as manufacturing test specifications, test software requirements, software intended use Test procedure, validation plan and report.
• Train test technicians on proper execution and troubleshooting.
• Work with suppliers to develop/improve their test methods.
• Design test equipment, mainly automated test equipment (ATE), including overall system design, digital and analog circuit design and instrumentation specification, test software programming.
• Supervise the design, fabrication and troubleshooting of functional test fixtures/stations.
• Validate test systems and test fixtures in FDA-regulated medical environment.
• Support verification and validation testing of products. Oversee the test system validation and quality buy-off. Other duties as assigned, such as core team membership, assistance for production/supplier troubleshooting.

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’s degree along with 7+ years of hardware test engineer or related experience or 5+ years with a master’s degree or advanced degree, preferably BS/MS in Electrical or Electronics Engineer, or equivalent.
• In-depth knowledge of Product development life cycle and test methodology.
• Strong written and verbal communication skills.
• Strong analytical and problem-solving skills.
• Desired English level: C1+ 90 - 99%
• Please submit resume in English

Preferred Qualifications:

• A strong product quality and test lead experience preferably in medical device domain.
• A natural attention to detail and a penchant for organizing and documenting.
• A good learner who can master complex software and quickly adapt to new tools and technologies.
• Ability to think logically and analytically in a problem-solving environment.
• Ability to work independently as well as work collaboratively as part of a team.
• Demonstrated experience communicating both technical and non-technical information across teams and departments.
• Follow company policy regarding ISO and FDA documentation and compliance for medical device