Senior Engineering Manager

Quasar Medical | Medical Device Manufacturer; Galway; On-site; EUR 120,000 - 150,000; Full time

Job summary

Quasar Medical, a Medical Device Manufacturer in Galway, Ireland, seeks a Senior Engineering Manager to lead NPD and customer programs within a contract manufacturing setting. You will drive design controls, stage-gate processes, and cross-functional collaboration to deliver successful launches.

The role requires strong leadership, regulatory knowledge, and commercial acumen to grow partnerships while maintaining quality, schedule, and budget.

Qualifications

• 10+ years’ experience in medical device engineering including NPD.
• 5+ years in a leadership role.
• Experience in customer-facing roles and contract manufacturing environments preferred.
• Strong knowledge of design controls, regulatory requirements, and product development processes.
• Proven experience in sustaining engineering, continuous improvement, and cost reduction initiatives.
• Proficiency in Lean, Six Sigma, and root cause analysis methodologies.
• Excellent leadership, communication, and problem-solving skills.

Responsibilities

• Lead and develop a high-performing, multidisciplinary engineering team across NPD, NPI and sustaining Engineering.
• Drive accountability for execution, performance, and continuous improvement.
• Deliver engineering programs across NPD, NPI, and sustaining on time, on quality, and within budget.
• Act as primary technical interface for customers across development and commercial programs.
• Support RFQs, proposals, and technical solution development.
• Translate customer needs into clear engineering execution strategies.
• Support scope definition, change management, and customer communication.

Skills

Leadership

Communication

Problem-solving

Commercial awareness

Stakeholder management

Regulatory knowledge

Education

Bachelor's or Master's in Engineering

Tools

ERP systems

FMEA

Manufacturing technologies

Job description

The Senior Engineering Manager will lead New Product Development (NPD) and customer programs within a medical device contract manufacturing environment. The role spans the full product lifecycle, including development, industrialization (NPI), and sustaining engineering.

The position requires strong customer-facing leadership, technical expertise, and commercial awareness to ensure projects are delivered on time, on quality, and on budget, while supporting business growth and long-term customer partnerships.

Essential Job Duties and Responsibilities

Leadership & Delivery

• Lead and develop a high-performing, multidisciplinary engineering team across NPD, NPI and sustaining Engineering
• Drive accountability for execution, performance, and continuous improvement
• Deliver engineering programs across NPD, NPI, and sustaining on time, on quality, and within budget
• Act as primary technical interface for customers across development and commercial programs
• Support RFQs, proposals, and technical solution development
• Translate customer needs into clear engineering execution strategies
• Support scope definition, change management, and customer communication

New Product Development (NPD)

• Lead cross-functional product development from concept through design, verification/validation, and transfer to manufacturing
• Ensure structured execution aligned to design controls and stage-gate processes
• Drive design reviews, risk management (e.g., FMEA), and technical decision-making
• Lead design transfer and New Product Introduction (NPI), ensuring manufacturing readiness, process robustness, and successful product launch
• Own engineering pipeline visibility, project intake, and prioritisation
• Assess feasibility, resource needs, and risk for incoming opportunities
• Balance portfolio across capacity, capability, and business priorities

Operational Excellence, NPI & Sustaining

• Lead New Product Introduction (NPI) to ensure successful product launch, process capability, and production ramp
• Own sustaining engineering activities, including design changes, issue resolution, and lifecycle management
• Drive process improvement, cost reduction, and manufacturing efficiency initiatives
• Partner with Operations, Quality, and Supply Chain to ensure stable, scalable production

Compliance & Quality

• Ensure all engineering activities comply with ISO 13485, FDA, and applicable regulatory standards

Education and Experience Requirements

• 10+ years’ experience in medical device engineering, including NPD
• 5+ years in a leadership role
• Experience in customer-facing roles and contract manufacturing environments preferred
• Strong knowledge of design controls, regulatory requirements, and product development processes
• Proven experience in sustaining engineering, continuous improvement, and cost reduction initiatives.
• Proficiency in Lean, Six Sigma, and root cause analysis methodologies.
• Excellent leadership, communication, and problem-solving skills.

Preferred Skills and Abilities

• Strong leadership and team development capability
• Proven ability to deliver complex programs in regulated environments
• Excellent communication and stakeholder management skills
• Commercial awareness (costing, scope control, and delivery)
• Experience with Lean, Six Sigma, and structured problem-solving
• Familiarity with ERP systems and advanced manufacturing technologies

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.

Travel Required

Minimal

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.