דרושים Design Assurance Manager ב-Boston Scientific ב-Costa Rica, Heredia

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.

Costa Rica-Heredia

Hybrid Roles:

About the role

This role will collaborate closely with all HR Operations, Centers of Excellence (COEs), HR Business Partners (HRBPs), and business leaders to ensure that HR Service Delivery is aligned with regional business needs, compliance requirements, and a strong employee experience. The Senior Manager will focus on operational execution, continuous improvement, and service optimization while supporting the evolution of HR processes in LATAM.

HR Service Delivery & Process Optimization

- Oversee HR shared services operations across LATAM, ensuring efficient, accurate, and compliant HR inquiry & transaction support.

- Implement and optimize HR service delivery processes, ensuring consistency across countries while addressing local business needs and regulatory requirements.

- Support the standardization of HR processes, policies, and systems to drive operational efficiency.

- Monitor key performance indicators (KPIs), service-level agreements (SLAs), and operational dashboards to track and improve HR service effectiveness.

Stakeholder Engagement & Partnership

- Gather feedback from stakeholders to identify gaps, pain points, and opportunities for HR service enhancements.

- Provide data-driven insights and recommendations to regional HR leadership on service performance, workforce trends, and process improvements.

Vendor & Third-Party Management

- Manage relationships with third-party HR service providers in LATAM, including HR BPOs, payroll vendors, benefits administrators, and compliance service providers.

- Oversee contract execution, vendor performance evaluations, and governance processes to ensure high-quality service delivery.

Compliance, Governance & Risk Management

- Ensure HR Service Delivery operations comply with employment laws, labor regulations, and internal policies across LATAM.

- Support audit and risk management processes, ensuring adherence to local legal requirements and HR governance frameworks.

Continuous Improvement & Regional Adaptation

- Identify and implement process improvement initiatives to enhance HR efficiency and the employee experience.

- Benchmark external best practices and bring innovative ideas into HR Service Delivery operations.

People Leadership & Capability Building

- Support HR capability-building initiatives, ensuring HR Service Delivery professionals are trained on policies, systems, and compliance requirements.

Required Qualifications:

- 7+ years of experience in HR Service Delivery, HR Operations, or Shared Services, preferably within LATAM.

- Strong understanding of HR service models, case management systems, and HR process optimization.

- Experience managing HR vendors (BPOs, payroll providers, benefits administrators, etc.) and overseeing vendor performance.

- Knowledge of HR compliance, labor regulations, and employment laws across LATAM.

Please submit your resume in English

Costa Rica-Heredia

Responsibilities:

• Drive project execution by leading governance to review projects roadmap, resourcing, status, and escalate/ mitigate risks.

• Prepare project plans using tools like Microsoft Project, Excel, and Word.

• Create, maintain, and monitor Jira items needed to accomplish project goals.

• Lead small to medium project teams to achieve timely project objectives.

• Define, monitor, and control scope through project meetings.

• Create, present, and maintain process flows and visuals using MS Visio.

• Create and execute project and communication plans with project teams.

• Schedule and facilitate regular project meetings.

• Follow up on tasks and issues.

• Develop and track project budgets.

• Identify, manage, and communicate project risks.

• Continuously capture, apply, and share best practices and lessons learned across the team.

• Help manage and maintain capacity plans for team members.

• Maintain roadmap and plan accordingly to achieve deliverables.

Minimum Qualifications:

• Bachelor's degree in Business Administration or any related field

• PMP certification is a big plus.

• 2+ years of Project Management Experience.

• Advance English Level

• Please submit resume in English

Preferred Qualifications:

• Demonstrated project management and change management experience.

• Leading scrum teams and scrum ceremonies.

• Effective communication skills (written, verbal, and presentation).

• High sense of urgency and commitment to execution.

• Proven adaptability, comfortable with change with a demonstrated ability to react and respond to a fast-changing environment.

• Work effectively with minimal supervision, with the courage to make decisions, take ownership and hold team and oneself accountable to results.

• Experience working in an agile environment.

Costa Rica-Heredia

Hybrid Roles:

About the role

• 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. o 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. o 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. o Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans. o Identifies and manages project dependencies and critical path items while ensuring project quality and utilizing and following appropriate methodologies (e.g. GSM). o Assures project quality by using standard development methodologies. o Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings. o Resolves project issues by working with team members, project customers, and others as appropriate. o Consults with internal project groups by sharing project management knowledge. o Conducts project post mortems and communicates lessons learned in order to identify successful and unsuccessful project elements. o 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.
• People Management: Manages medium-sized (occasionally multi-site) cross-functional development teams; leads teams effectively; provides input to functional managers on team and team member performance.
• Site PMO/Project Portfolio management: Oversees development, prioritization, resourcing, and status/tracking of site cross functional programs. Acts as liaison with other functions/sties for projects site is a contributor or stakeholder in.
• Communications and Reviews: Responsible for team and cross-functional communications; liaison between the team and the PIB; leads phase and business reviews, project meeting minutes, issues log, metrics, and other key communications.

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.

Required Qualifications:

• Bachelor's degree in Engineering/Science/Technical, plus 9-12 years of related work experience or an equivalent combination of education and work experience
• 6-8 years of experience leading a large team/organization
• Experience in the Medical Device Industry
• Desire English level C1+ 90-99%
• Please Submit resume In English