Product Engineer II

Product Engineer II

Responsible for leading and supporting projects to resolve customer and manufacturing issues using data‑driven structured problem‑solving methodologies. Works cross‑functionally with R&D, Quality, and Manufacturing teams to support New Product Introduction (NPI), validation, and qualification activities.

• Lead and execute structured problem‑solving (DMS, PSP, A3, 5 Whys) to resolve customer complaints, nonconformances, and manufacturing deviations, ensuring timely containment, root‑cause identification, and sustainable countermeasures.
• Partner with R&D, Quality, and Manufacturing to support NPI through design transfer, process characterization, validation (IQ/OQ/PQ), and readiness reviews.
• Own or support raw material change management, including impact assessments, supplier change evaluations, risk analysis, and execution of validation/verification plans to ensure compliance and product performance.
• Analyze process and quality data using DBS tools to monitor capability, identify trends, and drive continuous improvement in yield, cycle time, and product robustness.
• Drive and support change control processes (ECR/ECO) ensuring proper documentation, risk mitigation, and cross‑functional alignment in a regulated environment.

• Bachelor of Science (BS) in Engineering or related technical field.
• 3+ years of experience in product engineering, process engineering, quality engineering, or product development in a regulated manufacturing environment.
• Knowledge of manufacturing processes, preferably in polymeric materials (membranes, films, nonwovens), with the ability to apply that knowledge to solve problems and improve processes.
• Familiarity with change control processes (e.g., ECO/ECR) and raw material change management, including risk assessments and documentation in a regulated (cGMP/ISO) environment.
• Strong analytical, communication, and organizational skills.

• Experience with NPI, including validation (IQ/OQ/PQ) and design transfer activities.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. For more information about equal‑employment opportunities, see Danaher’s EEO statement.