Program Manager

Quasar Medical | Medical Device Manufacturer; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Quasar Medical seeks a Program Manager to direct multi-phase product development of medical devices from concept to market introduction and transfer to manufacturing. The role coordinates NPD, QA, Manufacturing, and Finance to meet scope, schedule, and budget objectives.

You will lead cross-functional teams, drive phase-gate reviews, and ensure compliance with quality systems while delivering projects on time and within budget.

Qualifications

• Bachelor's degree required; Master’s degree preferred.
• Degree focus in Mechanical or Biomedical Engineering is desired.
• Minimum of 5 years of post-college experience in medical device product design and development or other regulated industry.
• Minimum of 3 years of experience in program management or PMP® certification.

Responsibilities

• Serves as the client’s primary point of contact into Quasar for all project-related matters.
• Achieve On-Time Delivery project performance objectives and report progress to stakeholders.
• Writes and reviews customer proposals and assists in business development and client relationships.
• Prepares project plans specifying phases, tasks, durations, resources, and costs.
• Holds core teams accountable to schedule and deliverables.
• Track lessons learned and manage best practices.
• Participate in Phase Gate Reviews and ensure PMO compliance.
• Manage resource planning and staffing for projects.
• Ensure accurate time tracking and data reporting for projects.
• Resolve conflicts and establish escalation paths.
• Conduct project closeout meetings and post-completion reviews.

Skills

Project Management

FDA QSR knowledge

ISO 13485 awareness

Cross-functional leadership

Budget management

Communication skills

Education

Bachelor's degree

Master’s degree preferred

Mechanical or Biomedical Engineering

Tools

Microsoft Project

MS Office

Online collaboration tools

Job description

JOB SUMMARY

The Program Manager directs the multi-phase product development process of medical devices and components from concept through market introduction and transfer to manufacturing. Quasar’s Project Management Teams manage cross functional projects which may include, New Product Development, Manufacturing Transfer, CIPs and Semi-Automation. The Program Manager is responsible to assure a project or multiple projects meet Customer expectations – defined by project scope, on time delivery - defined by schedule and financial target - defined by budget objectives. Project managers work with NPD, BD / KAM, Quality, Manufacturing, Finance, and other functions across Quasar.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

• Serves as the client’s primary point of contact into Quasar for all project-related matters
• Achieve On-Time Delivery project performance objectives and report out progress to relevant Stakeholders at regular intervals.
• Writes and reviews customer proposals, assists in business development activities and client relationship management
• Prepares project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs
• Hold core teams accountable to schedule and deliverables.
• Track lessons learned and manage best practices.
• Participate in and lead as required Phase Gate Reviews.
• Ensure compliance with Quasar’s Quality System procedures.
• Manage resource planning and staffing activities for specific projects.
• Ensure accurate time tracking on projects as required.
• Maintain accurate project data reporting and ensure accurate data report outs.
• Resolve project conflicts and establish escalation path on all projects.
• Ensure project closeout meetings and post-completion reviews are conducted.
• Clearly communicate roles, expectations, and accountabilities to all team members on a regular basis.
• Be a resource to facilitate the resolution of project issues by team members.
• Drive compliance and remove barriers to achieve strategic initiatives and goals.
• Ensure compliance to PMO processes, procedures, and use of PMO templates.
• Regularly keep management informed of risks, issues, and status of on-going projects.
• Understand and comply with Quality system and business practices necessary to complete job function.
• Work with functional managers as needed to meet project objectives, on-time delivery, and identify/resolve resourcing issues.
• Sets project budgets, tracks cost to budget and manages budget for on-cost delivery. Reviews and approves invoices and assesses Quasar financial exposure throughout project
• Directs day-to-day activities for multiple project teams through managing project plans, resources, status reporting, issue resolution, risk management, and accountability for deliverables
• Manages multiple concurrent projects or programs of varying size, scope, and complexity for strategic customers
• Support and contribute to initiatives from the Project Management Office (PMO)
• Coordinate with other project managers running sub program deliverables
• All other duties as assigned

EDUCATION & EXPERIENCE REQUIREMENTS

• Bachelor's degree required; Master’s degree preferred.Degree focus in Mechanical or Biomedical Engineering is desired.
• Minimum of 5 years of post-college experience is required in medical device product design and development or other regulated industry
• Minimum of 3 years of experience in program management or Project Management Professional (PMP®) certification
• Project Management Professional (PMP®) Certification or equivalent training required

SKILLS & ABILITIES

• Knowledge of catheters, delivery systems, dilators, or braided shafts desired
• Proficient knowledge of FDA QSR and ISO 13485 medical device regulations
• Demonstrated professional communication skills through both verbal and written means regarding project and technical matters
• Ability to interact with client companies in a professional manner and with integrity
• Demonstrated ability to problem solve and manage in situations of ambiguity and technical uncertainty
• Ability to negotiate
• Motivate and engage team members while demonstrating respect for people
• Excellent time-management and organization skills
• Manage cross-functional team in a matrix organization with multiple stakeholders
• Proficiency with Microsoft Project, on-line collaboration tools, and databases
• Flexibility, persistence, and resourcefulness
• Customer passion, energy, a drive to succeed, and an entrepreneurial spirit

WORKING CONDITIONS & PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to look at a computer screen, reports and other documents. The employee is regularly required to use their hands on a computer keyboard or a calculator. The employee is regularly required to sit, talk, hear and interact with other employees.The employee is regularly required to stand and walk.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Statement

Quasar Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.