Principal Pd Project Management Specialist (Medtech)

TL;DR

Principal PD Project Management Specialist (Medtech): Supporting the development and effective implementation of processes and procedures to support development and commercialization of CRDN products with an accent on product development design processes (PDP). Focus on maintaining and improving quality programs, systems, processes, and procedures that ensure compliance with policies and meet performance expectations.

Location: Expected to be onsite in Galway, County Galway, Ireland 3-4 days per week.

Salary: 78,320.00 EUR - 117,480.00 EUR

Company

hirify.global leads global healthcare technology and boldly attacks the most challenging health problems facing humanity by searching out and finding solutions.

What you will do

• Sustain and support the development of product development design processes (PDP) to support both coronary and RDN portfolio within CRDN OU.
• Maintain and improve quality programs, systems, processes, and procedures that ensure compliance with policies and meet performance expectations conforming to established internal and external standards and guidelines.
• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Provide support for QMS audit and inspection preparation specific to PDP procedures and processes at all CRDN sites, including resolution of audit findings.
• Collaborate cross functionally with other CRDN functions on design control related initiatives.
• Provide PDP and Design Control training to CRDN program teams and provide expertise for DHF, DDP and other outputs as needed.

Requirements

• Qualified to Degree level in Engineering / Science or related discipline and minimum of 7 years of relevant experience.
• Design Control; ISO 13485 expertise.
• Hardware and/or software medical device project management or development experience.
• Dynamic team member and leader who can work effectively and proactively on cross functional, global teams.
• Excellent communication, organization, presentation & leadership skills.
• Experienced with MS project, MS Office and other PMO tools.

Nice to have

• PMP, Agile and/or Master’s in Project Management is desirable

Culture & Benefits

• hirify.global offers a competitive Salary and flexible Benefits Package.
• A commitment to our employees lives at the core of our values.
• We recognize their contributions.
• They share in the success they help to create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.