Sr Laboratory Engineer
Main Responsibilities
Serve as subject-matter expert for combination products and drug-delivery systems, with responsibility for defining and applying appropriate testing and analytical strategies.
Design, implement, and execute material analytical methodologies and verification activities to demonstrate compliance with defined design inputs, including worst-case conditions and risk-based considerations.
Plan, prepare, perform, and document material analysis and testing campaigns in accordance with internal quality systems and regulatory requirements.
Interpret and correlate analytical results with material properties, manufacturing processes, and device performance, translating findings into clear, actionable recommendations.
Select, qualify, and technically manage external laboratories and outsourced testing activities.
Collaborate closely with R&D, Quality, Regulatory Affairs, Manufacturing, and external partners to support product development and lifecycle activities.
Build, lead, and develop a high-performing laboratory team, including recruitment, onboarding, training, mentoring, and performance management.
Plan and manage laboratory resources and budget, aligning capacity and investments with business needs and the 2030+ strategic roadmap.
Act as the primary point of contact for laboratory-related topics, providing regular updates to management on performance, risks, capacity, and progress during the defined 1.5-year build-up phase.
Skills and Qualification
- Bachelor’s degree or higher, in analytical chemistry, biomedical engineering, mechanical engineering, material science
- Strong management and leadership capabilities to establish, develop, and operate an efficient, well-connected testing laboratory within the local (U.S.) management environment while aligning with the global organization
- Solid professional background in highly regulated industries, such as Medical Technology (MedTech), with a strong understanding of regulatory, quality, and compliance requirements
- Strong team player and self-starter with the ability to operate independently under minimal supervision; proactive, hands-on, and solution-oriented mindset with a persistent focus on execution and results in fast-paced, evolving environments
- Proven experience in mechanical device testing and relevant analytical technologies and strong foundational knowledge of polymer science, chemistry, metallurgy, and mechanics
We Offer
- Competitive compensation package
- Modern working environment with state-of-the-art facilities and technologies
- Challenging assignments in a fast-growing and innovative industry
- Position in a dynamic, international team of highly skilled professionals
- Variety of opportunities for personal and professional development within a global organization