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Principal design engineer - global npd

Galway
Cpl Healthcare
Design engineer
Posted: 2 May
Offer description

Principal Product Design Engineer – Global NPD
Athenry (Option to apply for Hybrid work flexibility after probationary period) | Permanent
We’re partnering with an innovative global wellness and medical‑technology business to hire a Principal Product Design Engineer – Global NPD. This is the senior technical authority role for regulated device and general wellness products, leading architecture and design from concept through commercialisation.
You will own product specifications, design integrity and external engineering coordination, ensuring all technical outputs meet regulatory, quality and commercial requirements across a fast‑growing global portfolio.
The opportunity

Lead technical architecture and system design for electromechanical and wellness‑based products from concept to launch.
Act as the company’s technical authority with external engineering and testing partners.
Play a key role in a newly built NPD organisation alongside Regulatory, Quality and Program Management.

What you’ll be doing
Technical architecture & specifications

Define and author Product Requirement Documents (PRD), User Requirement Specifications (URS) and detailed Technical Specifications.
Establish system architecture for electromechanical devices and general wellness products.
Ensure full traceability between design inputs, outputs, verification plans and risk documentation.
Approve final product specifications prior to design freeze.

Design control & risk management

Lead design risk analysis activities (DFMEA, PHA).
Define verification and validation strategies aligned to regulatory and quality requirements.
Ensure compliance with design control throughout development and support regulatory submissions with robust technical documentation.

External engineering & consultant management

Act as the organisation’s technical authority when engaging mechanical, firmware, electrical, industrial design and test consultants.
Define scopes of work and performance expectations for external partners.
Review and approve drawings, firmware specs, test reports and other technical deliverables, translating them into internal‑compliant documentation.
Identify and escalate technical risks or scope deviations early.

Cross‑functional collaboration & innovation

Partner closely with Regulatory to embed compliance into product design from the outset.
Align with Quality on verification/validation plans, testing protocols and documentation readiness.
Coordinate with Program Managers on technical milestones and critical path dependencies.
Drive device platform improvements, evaluate emerging technologies and support roadmap feasibility assessments.
Ensure technical documentation is audit‑ready and inspection‑ready at all development stages.

What we’re looking for

Bachelor’s degree (or higher) in Engineering, Materials Science or a related discipline.
10+ years’ R&D/NPD experience in a relevant industry, ideally medical device or comparable sectors (electronics, mechanical, automotive, etc.).
Strong knowledge of engineering theory, design principles, work measurement methods, FMEA, test development and applicable regulatory/industry standards.
Experience working within ISO 9001:2015 and ISO 13485 environments.
Proven ability to lead technical design in electromechanical devices is a strong advantage.
Demonstrated ability to balance compliance and commercial realities in a fast‑moving environment.
Experience mentoring and coaching engineers; comfortable with supervisory responsibilities.
Track record of delivering in settings with multiple demands, shifting priorities, ambiguity and rapid change.
Comfortable working independently and as part of a global, cross‑time‑zone team; willingness to travel up to c.10% per year

Education, Experience and Competencies: (the above bullet points encompass all qualifications).
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