Engineer II NPD

Quasar Medical | Medical Device Manufacturer; Galway; On-site; EUR 60,000 - 90,000; Full time

Job summary

Quasar Medical, a medical-device manufacturer in Ireland, seeks an NPD Engineer II to drive development and commercialisation of catheter-based devices. You will lead technical workstreams from feasibility to manufacturing transfer, coordinating with manufacturing, quality, and supply chain.

You will design robust product solutions, manage risk, and deliver design verifications, validations, and documents to support regulatory approvals and product launches.

Qualifications

• Level 8 bachelor’s degree in Mechanical, Biomedical, Manufacturing, or a related technical discipline.
• 3 to 5 years’ relevant engineering experience in medical-device product development, manufacturing engineering, or a similar regulated industry.
• Experience in product and process development, including prototype builds, engineering testing, technical problem-solving and transfer to manufacturing.
• Experience working within a regulated quality system, with practical knowledge of design controls, risk management, verification, validation and technical documentation.
• Demonstrated ability to independently plan and deliver assigned engineering activities, analyse technical data and develop evidence-based solutions.
• Experience with balloon catheters, braided shafts, delivery systems or other minimally invasive medical devices is highly desirable.

Responsibilities

• Design and develop catheter-based medical devices, translating customer and product requirements into practical, manufacturable solutions.
• Develop and optimise product designs, materials, manufacturing processes, tooling, fixtures and test methods from feasibility through commercialisation.
• Plan and execute prototype builds, engineering trials, process development, testing and technical investigations, applying appropriate engineering, statistical and experimental methods.
• Generate and maintain design and development documentation in accordance with applicable quality-system and design-control requirements, including specifications, drawings, protocols, reports, risk documentation and manufacturing instructions.
• Support design reviews, risk management, design verification and validation, process validation and design transfer, ensuring appropriate traceability of requirements and supporting evidence.
• Analyse product and process performance, investigate failures and technical issues, identify root causes, and develop appropriate corrective or risk-mitigation actions.
• Develop manufacturing processes and controls capable of consistently meeting product, customer, quality and regulatory requirements.
• Lead assigned technical activities through manufacturing transfer, pilot builds, validation, production launch and early commercial manufacture, working closely with Operations, Quality and Supply Chain.
• Deliver assigned engineering activities against agreed project scope, timelines, budget and quality requirements, proactively identifying and escalating technical risks, issues and dependencies.

Skills

Problem solving

Analytical thinking

Documentation

Cross-functional collaboration

Regulatory awareness

Education

Bachelor’s degree in Mechanical, Biomedical, Manufacturing or related technical discipline

Job description

Job Summary

The NPD Engineer II is responsible for the development and commercialisation of catheter-based and other minimally invasive medical devices for Quasar Medical’s customers. The role supports projects from feasibility and concept development through design verification, process validation, manufacturing transfer, and commercialisation.

Working as part of a cross-functional project team, the engineer will develop product designs, manufacturing processes, fixtures, tooling, test methods, and technical documentation. The role will independently lead defined technical workstreams, investigate technical issues, manage assigned risks and deliverables, and communicate progress to internal stakeholders and customers.

Essential Job Duties and Responsibilities

• Design and develop catheter-based medical devices, including balloon catheters, braided shafts and delivery systems, translating customer and product requirements into practical, manufacturable solutions.
• Develop and optimise product designs, materials, manufacturing processes, tooling, fixtures and test methods from feasibility through commercialisation.
• Plan and execute prototype builds, engineering trials, process development, testing and technical investigations, applying appropriate engineering, statistical and experimental methods.
• Generate and maintain design and development documentation in accordance with applicable quality-system and design-control requirements, including specifications, drawings, protocols, reports, risk documentation and manufacturing instructions.
• Support design reviews, risk management, design verification and validation, process validation and design transfer, ensuring appropriate traceability of requirements and supporting evidence.
• Analyse product and process performance, investigate failures and technical issues, identify root causes, and develop appropriate corrective or risk-mitigation actions.
• Develop manufacturing processes and controls capable of consistently meeting product, customer, quality and regulatory requirements.
• Support equipment qualification, process characterisation, test-method validation and process validation activities, including IQ/OQ/PQ where applicable.
• Lead assigned technical activities through manufacturing transfer, pilot builds, validation, production launch and early commercial manufacture, working closely with Operations, Quality and Supply Chain.
• Deliver assigned engineering activities against agreed project scope, timelines, budget and quality requirements, proactively identifying and escalating technical risks, issues and dependencies.
• Participate in customer meetings, design reviews and technical discussions, clearly presenting technical results, conclusions and recommendations.
• Provide technical direction and support to technicians, suppliers and other project contributors, and contribute to project planning, quotations and resource estimates as required.

Job Description

Education and Experience Requirements

• Level 8 bachelor’s degree in Mechanical, Biomedical, Manufacturing, or a related technical discipline.
• 3 to 5 years’ relevant engineering experience in medical-device product development, manufacturing engineering, or a similar regulated industry.
• Experience in product and process development, including prototype builds, engineering testing, technical problem-solving and transfer to manufacturing.
• Experience working within a regulated quality system, with practical knowledge of design controls, risk management, verification, validation and technical documentation.
• Demonstrated ability to independently plan and deliver assigned engineering activities, analyse technical data and develop evidence-based solutions.
• Experience with balloon catheters, braided shafts, delivery systems or other minimally invasive medical devices is highly desirable.

Preferred Skills and Abilities

• Strong technical problem-solving and analytical skills, with the ability to develop practical, evidence-based engineering solutions.
• Sound understanding of medical-device product development, manufacturing processes, materials, engineering drawings, tolerances and test methods.
• Ability to plan, prioritise and independently execute technical activities while managing multiple project deliverables.
• Strong technical documentation, data analysis and communication skills, with the ability to clearly present findings and recommendations.
• Effective interpersonal skills with the ability to work collaboratively with customers, cross-functional teams, technicians and suppliers.
• Sound engineering judgement with an understanding of technical risk, manufacturability, product quality, cost and project timelines.

Working Conditions and Physical Demands

While performing the duties of this job, the employee is regularly required to look at a computer screen, reports and other documents. The employee is regularly required to use their hands on a computer keyboard or a calculator. The employee is regularly required to sit, talk, hear and interact with other employees.The employee is regularly required to stand and walk.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

On-site role in a cleanroom and controlled manufacturing environment.

Equal Opportunity Statement

Quasar Medical provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.