Program Manager - NPD

HERO Recruitment Ltd.; Galway; On-site; EUR 90,000 - 130,000; Full time

Job summary

HERO Recruitment Ltd. in Galway is partnering with a global medical device company to recruit a Senior NPD Program Manager for its site.

You will lead customer development programs for Class II and III devices from concept to commercial, acting as the primary contact for the customer. Reporting to the NPD Director, you will spearhead cross-functional teams through all development stages, ensure design verification/validation, and manage scope, timelines and budgets.

Qualifications

• 10+ years in the medical device industry with Class II/III experience.
• Strong stakeholder management and technical presentation skills.
• Experience overseeing design verification and validation activities.
• Proven ability to manage scope, budgets and resources; develop Statements of Work.

Responsibilities

• Own the customer relationship on assigned programmes, leading meetings, technical reviews and project updates.
• Lead cross-functional teams through all phases of development, including design reviews, verification, validation and design transfer.
• Manage project scope, schedule, budget, resources and risk, with clear reporting to customers and internal stakeholders.
• Develop and negotiate Statements of Work, and manage scope changes through delivery.
• Support the Business Development team with opportunity assessments, proposals and customer visits.
• Ensure compliance with FDA Design Controls and ISO 13485.

Skills

Customer-facing leadership

Cross-functional team leadership

FDA Design Controls

ISO 13485 compliance

Education

Engineering degree

PMP certification

Job description

Senior NPD Program Manager
Galway | Permanent, Full-Time |

HERO Recruitment is partnering with a global medical device contract development and manufacturing company to hire a Senior NPD Program Manager for its Galway site. Reporting to the NPD Director, you will lead customer development programmes for Class II and Class III medical devices from concept through to commercial, acting as the main point of contact for the customer throughout.

The role

• Own the customer relationship on assigned programmes, leading meetings, technical reviews and project updates.
• Lead cross-functional teams through all phases of development, including design reviews, verification, validation and design transfer.
• Manage project scope, schedule, budget, resources and risk, with clear reporting to customers and internal stakeholders.
• Develop and negotiate Statements of Work, and manage scope changes through delivery.
• Support the Business Development team with opportunity assessments, proposals and customer visits.
• Ensure compliance with FDA Design Controls and ISO 13485.

What you will bring

• A degree in Engineering or a related technical discipline.
• 10+ years' experience in the medical device industry, including Class II and Class III device development.
• Proven expertise in catheter-based devices (balloon catheter and/or braided shaft technologies).
• Significant customer-facing experience, including technical presentations and stakeholder management.
• Experience leading design verification and validation activities.
• A track record of managing project scope, budgets and resources, and of developing Statements of Work.
• CDMO experience and a PMP or equivalent certification are an advantage.