Device Development Engineer

Job Description

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Job Title: Reports To:Principal Systems Engineer

Our client is an exciting, rapidly growing publicly listed clinical-stage biopharmaceutical business focussed on establishing best-in-class teams across all its functions. In 2021, the company successfully completed an IPO on the Nasdaq. To date, the company has raised $300 million +, and is engaged in a major expansion of its team in Ireland.

This role will be filled on a permanent basis. The role is hybrid and is based in Dublin HQ.

Job Summary:

Reporting to the Principal Systems Engineer, this role will support the design & development of proprietary drug-delivery medical devices and combination products, with responsibilities for engineering design, verification, validation, and transfer to manufacturing. Through collaboration and technical oversight of external development partners, the Development Engineer will be focused on ensuring that the development of robust engineering solutions will deliver safe and effective products to market.

Key Duties and Responsibilities:

Collaborate with cross-functional development teams (design engineers, device & drug manufacturing, regulatory, marketing, clinicians, etc) to bring innovative products to market.

Support the definition of User Needs and Design Input Requirements through collaboration with the CDMO and relevant internal and external stakeholders.

Interpretation of regulations, agency guidelines and standards, including translation into design requirements to ensure compliance.

Technical review and approval of all design outputs and specifications.

Apply good engineering analysis on new designs and product concepts.

Review of technical reports, verification test protocols, test method development and verification reports.

Review of mechanical, electrical and software engineering analysis or testing.

Identify technical risk early in the development lifecycle and introduce controls and mitigations to de-risk the product and project.

Support characterization testing, DOE's and design verification strategies to ensure robust product performance.

Support the

application of a Risk Management process to the development lifecycle.

Oversee the resolution of cross-discipline design issues or anomalies found during testing.

Knowledge of DFM principles and ensuring implementation during the development process.

Support human factors and design validation activities to ensure that use-related risks are sufficiently mitigated.

Management of device build planning to support development testing, verification & validation and clinical studies.

Support external manufacturing operations during manufacturing process development, scale-up, and technology transfer.

Support technical root cause analysis, incident investigations and troubleshooting issues related to device design, manufacturing equipment and processes.

Education and Experience:

Bachelors or Masters qualification in Science, Engineering or related field

5+ years related experience in medical device development.

Technical expertise in electromechanical medical devices and knowledge of emerging technologies.

Knowledge of EU MDR 2017/745, ISO 13485, 21 CFR Part 820 and ISO 14971 is desired.

Knowledge of the relevant regulations and guidelines for inhalation medical devices and combination products is desirable.

Experience interacting with third party service providers required.

Knowledge and Abilities:

Self-motivated with the ability to work in a fast-paced environment.

Acute attention to detail supported by the ability to see the big picture.

Creative, flexible, and innovative team player.

Excellent written and verbal communication skills in English is a must.

Strong organizational, planning, problem-solving, analytical and decision-making skills.

Focused on making data driven decisions.

A self-starter and comfortable working on their own initiative.

Ability to perform multiple tasks simultaneously under direction and prioritise workload.

Maintain a professional and positive attitude and present clear instruction/direction to team members.

Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team.

Flexible, able to adjust, embrace and drive change.

An entrepreneurial, business-oriented mindset and a strong fit with our client's team and willing to "roll their sleeves up.

Resilient, energetic, and enthusiastic.

CVs to gavin@rftgroup.ie