OverviewJob SummaryResponsible for hands-on technical and team leadership of Integration Engineers across assay, reagent, software, hardware, instrumentation, and system verifcation activities. The role will help to define integration approaches, resolve complex system issues, and ensure technically rigorous verification evidence for automated and manual testing systems.
ResponsibilitiesKey AccountabilitiesTechnical and Team Leadership
- Lead Integration Engineers through technical planning and execution of system integration engineering and verification activities across assay, reagent, software, hardware, and in-strumentation interfaces.
- Expands team depth through mentoring, shared methods, knowledge transfer, and perfor-mance management.
- Build Integration Engineer team capability in systems thinking, design controls, verification strategy, scientific and statistical methods, technical writing, traceability, risk management, and investigation practices.
- Provide focused people leadership of Integration Engineers necessary to support technical execution, including assignment of work based on competency, removal of technical barri-ers, timely feedback, and development planning.
Design Verification & Validation
- Apply requirements-based, risk-based, and evidence-driven approaches to verification planning, execution, analysis, and reporting.
- Assess integration and verification readiness by evaluating requirements testability, equip-ment and method readiness, dependencies, technical risks, and availability of qualified re-sources.
- Review and approve V&V deliverables by evaluating assumptions, methods, acceptance criteria, analyses, traceability, and conclusions for scientific and engineering rigor.
Regulatory & Compliance
- Integrate design control, documentation, traceability, and procedural requirements into technical execution.
- Collaborate with regulatory affairs to ensure compliance with relevant industry standards and regulations.
Problem-Solving and Risk Assessments
- Use data, experimentation, structured investigation, and cross-functional expertise to resolve complex system and product behavior.
- Identify technical issues and ensure timely evaluation, escalation, and resolution based on product risk and project impact.
- Facilitate advanced troubleshooting and root-cause analysis using system data, experi-mental evidence, structured problem solving, and cross-functional expertise.
- Performs other duties and responsibilities as assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships- Works in cross-functional relationships with team members of Quality, Regulatory, Marketing, Operations, and other R&D functions.
- Coordination of project deliverables with Systems Integration Management, PMO, and the other cross functional teams is required to meet milestones.
QualificationsMinimum Knowledge & Experience required for the position:- Master's Degree (MA); or equivalent combination of education and experience
- Minimum of 10 years of related work experience
- Science or Engineering Degree (Biomedical Engineering preferred)
- Advanced knowledge of the design control process for medical devices (IVD preferred)
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:- Strong verbal and written communication skills specifically related to complex biological concepts and technical documentation.
- Effective collaborator across departments and with cross-functional teams.
- Demonstrates ability to priortize and manage multiple workloads efficiently in a fast-paced environment.
- Intermediate proficiency in Microsoft Office (Word, Excel) and specialized systems (TrackWise, MasterControl, SharePoint).
- Receptive to feedback and direction; works cooperatively with managers and peers.
- Proven ability to work independently and as part of a team.
- Organized and detail-oriented with strong problem-solving skills.
- Committed to continuous improvement and operational excellence.
- Maintain records and files of work and revisions according to procedures and processes by following cGDP.
Travel requirements:Minimal - less than 5%.
ClosingIf you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
