Senior Project Engineer

Embecta Corp.; Leinster; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Embecta Corp. is seeking a Senior Project Engineer to lead cross‑functional projects supporting the injection products portfolio. You will drive regulatory compliance, coordinate changes, and enable business continuity and growth across the lifecycle.

You will collaborate with leadership, SMEs, and project teams to plan, track, and execute initiatives, ensuring timely delivery, quality, and budget adherence in a regulated medical devices environment.

Formación

• Bachelor's degree in an engineering or technology-related discipline.
• Minimum 5 years of experience in a regulated Medical Devices and/or Pharmaceutical industry.
• Experience with product lifecycle management in high-volume manufacturing environments.
• Solid understanding of regulatory requirements, quality systems, and design controls.

Responsabilidades

• Lead cross functional project teams delivering initiatives that impact compliance, form/fit/function, cost reduction, line extensions, and other business opportunities.
• Act as a primary liaison between business leadership, functional management, and project team members.
• Collaborate with functional managers to ensure appropriate resource allocation and discretionary spending to meet project timelines.
• Plan and facilitate regular project meetings to ensure all stakeholders are informed, aligned, and completing assigned actions.
• Work closely with Technical Subject Matter Experts (SMEs) to ensure all project tasks are clearly defined, planned, and executed.
• Assess the impact of change requests, including risks, costs, and schedule implications.
• Manage, and in some cases execute, engineering change deliverables through all stages of the Change Control process.
• Provide regular project status updates to senior management, covering quality, schedule, cost, and overall progress.
• Promote strong project planning, execution discipline, and rigor across all project activities to ensure successful outcomes.

Conocimientos

Project management

Cross-functional teams

Regulatory compliance

Quality systems

Educación

Bachelor's degree in engineering

Herramientas

PLM systems

Descripción del empleo

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.

The Senior Project Engineer leads cross‑functional projects that support Embecta’ s injection products portfolio. This role plays a key part in delivering projects that ensure regulatory compliance, support product changes, and enable business continuity and growth. The position offers the opportunity to manage initiatives that are critical to the long‑term success of the business.

Responsibilities

• Lead cross functional project teams delivering initiatives that impact compliance, form/fit/function, cost reduction, line extensions, and other business opportunities.
• Act as a primary liaison between business leadership, functional management, and project team members.
• Collaborate with functional managers to ensure appropriate resource allocation and discretionary spending to meet project timelines.
• Plan and facilitate regular project meetings to ensure all stakeholders are informed, aligned, and completing assigned actions.
• Work closely with Technical Subject Matter Experts (SMEs) to ensure all project tasks are clearly defined, planned, and executed.
• Assess the impact of change requests, including risks, costs, and schedule implications.
• Manage, and in some cases execute, engineering change deliverables through all stages of the Change Control process.
• Provide regular project status updates to senior management, covering quality, schedule, cost, and overall progress.
• Promote strong project planning, execution discipline, and rigor across all project activities to ensure successful outcomes.

Experience And Education

• Bachelor’s degree in an engineering or technology‑related discipline.
• Minimum 5 years’ experience working in a regulated Medical Devices and/or Pharmaceutical industry

Knowledge, Skills And Abilities

• Experience with product lifecycle management in high‑volume manufacturing environments.
• Solid understanding of structured product development processes, regulatory requirements, and quality systems.
• Experience with ISO standards, GMP guidelines, FDA regulations, medical device design controls, and manufacturing scale‑up processes.
• Excellent interpersonal and communication skills, with the ability to efficiently interact with diverse audiences and stakeholders
• Proven ability to work effectively both independently and as part of a cross‑functional team.
• Strong attention to detail and commitment to quality and compliance

embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.