An innovative medical device company specialising in the development of products to treat women's health is looking to recruit a leader for their software engineering function. The organisation is one of the fastest growing women's health MedTech companies globally.

The Position

Due to a recent acquisition, they now seek an experienced Software Engineering Lead to join their Leadership Team, based out of their Galway HQ. The main purpose of this role will be to manage all software activities for the medical device development process, ensuring that software design, development, and maintenance adhere to relevant regulatory requirements, standards, and guidance for all markets.

The successful candidate will have the opportunity to create and develop the entire software development function for the business. They will need experience working with software as a medical device (SaMD). Further responsibilities include.

• Develop and comply with company policies, procedures, and standards, while overseeing software deliverables.
• Coordinate with external contracted parties to deliver project needs, ideally utilising Agile Product development methodologies.
• Document software development and maintenance procedures to ensure replicability and compliance with standards such as FDA, ISO14971, ISO62304, ISO62366, ISO60601, ISO60601-x, HIPPA, and GDPR.
• Perform and document risk analysis according to regulatory and procedural requirements.
• Generate and coordinate software deliverables in line with ISO62304 Class lla medical device standards. This includes software requirements, specifications, verification/validation test plans, recording test progress and results, and resolving failures or deviations with relevant quality personnel.
• Develop standards and procedures to determine product quality and release readiness.
• Ensure user risks arising from software changes are risk assessed and human factors studies reviewed for update as required.
• Track and manage bug fixes through sub-suppliers testing, documenting and reporting to developers.
• Collaborate with vendors to identify, document, and maintain cybersecurity processes and associated deliverables required by FDA/EU requirements.
• Support generation of regulatory and other queries.

The Person

• Experienced software development engineer with a demonstrated track record in meeting ISO62304 requirements for software development within the medical device industry.
• Strong business acumen with demonstrated track record in managing key stakeholder's relationships.
• You will be proficient in design verification and validation for software, including integration into product design control process, encompassing integration and system testing.
• Knowledge of software Quality Assurance (QA) methodologies, tools, and processes.
• Familiarity with with all relevant ISO standards.
• You will have a solution orientated mindset with exceptional communication skills.
• A team player with excellent project management skills.

The Benefits

• Flexible working.
• Pension.
• Bonus.
• Healthcare.

To learn more, apply online or contact Ciaran McCaughey at HRM Search Partners on +353 1 6321830 or please submit an updated CV.