Sr Laboratory Engineer

SHL Medical; North Charleston (SC); On-site; USD 100,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Modern facilities and technology

Global team of professionals

Opportunities for personal and career

Job summary

SHL Medical seeks a Senior Testing Engineer for its NCHS Laboratory to establish and operate a state‑of‑the‑art analytics lab for polymer material analysis of medical devices.

You will lead a qualified team, ensure compliance with quality, regulatory, and safety standards, and collaborate with R&D, Regulatory Affairs, and Manufacturing to support product development and lifecycle activities.

Qualifications

• Bachelor’s degree or higher in analytical chemistry, biomedical engineering, mechanical engineering, or material science.
• Experience leading a regulated laboratory in MedTech or a related field.
• Strong knowledge of polymer science, analytical testing methods, and device performance.
• Proven ability to manage cross-functional teams and projects in fast-paced settings.

Responsibilities

• Establish, operate, and continuously improve a state‑of‑the‑art laboratory for polymer material analysis and testing of medical devices.
• Serve as subject‑matter expert for combination products and drug‑delivery systems, defining testing strategies.
• Design and implement material analytical methodologies to demonstrate regulatory compliance and risk considerations.
• Plan and document material analysis campaigns in line with quality systems and regulatory requirements.
• Interpret results and translate findings into actionable recommendations for manufacturing and R&D teams.
• Oversee SOPs, work instructions, and safety rules to ensure compliance and quality.
• Manage equipment qualification, calibration, and accreditation activities.
• Select and manage external labs and outsourced testing.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, and partners on lifecycle activities.
• Build, lead, and develop a high‑performing laboratory team, including recruitment and training.
• Plan and manage laboratory resources and budget, aligning with the 2030+ roadmap.

Skills

Leadership

Polymer science

Mechanical testing

Regulatory compliance

Team development

Education

Bachelor’s degree or higher in analytical chemistry/biomedical engineering/mechanical engineering/material science

Job description

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Senior Testing Engineer – NCHS Laboratory is responsible for establishing, implementing, and operating a state‑of‑the‑art laboratory for polymer material analysis and testing of AI devices, ensuring the delivery of high‑quality, compliant analytical services. The role ensures that laboratory setup and operations fully comply with applicable quality management systems, regulatory requirements, and safety standards, and are effectively integrated into the local management and organizational structure. The Senior Testing Engineer, together with the support from the global Testing function, will build and develop a qualified laboratory team in alignment with customer project demands, approved budgets, and the strategic objectives outlined in the 2030+ roadmap.

Main Responsibilities

• Establish, operate, and continuously improve a state‑of‑the‑art laboratory for polymer material analysis and performance testing of medical devices and combination products.
• 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.
• Establish, enforce, and continuously improve laboratory SOPs, work instructions, templates, and safety rules, ensuring full compliance with internal and external standards.
• Oversee laboratory operations, including equipment qualification, calibration, certification, and accreditation.
• 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
• Various opportunities for personal and professional development within a global organization

SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com