The Process Engineer implements manufacturing methods and processes for the production of biomedical electro-chemistry sensor products. Responsible for driving continuous improvement in equipment, training, processes, and environment controls in support of yearly Safety, Quality, Delivery, and Cost objectives. This position balances daily production support activities with impactful project implementation. An impactful and visible member of the Operations team, this position interacts with members of the operations, quality, finance, and R&D teams continually to drive the implementation of the best possible solutions and improvements.
Provide expert analysis, testing and evaluation of manufacturing processes and techniques.
Provide direct support to manufacturing and participate in training of production operators and engineers on new processes and design for manufacturing projects as required.
Identify, plan, and execute projects to achieve capacity, cost, yield, reliability and/or cycle time improvements.
Generate detailed written procedures and specifications for processes, tools, and equipment, including Standard Work with Visual Management, Validations & Revalidations – Installation, Operational, Performance Qualifications (IQ/OQ/PQ), and assessments of Process Capability (cPK).
Recommend and apply Danaher Business Systems (DBS)/ Lean Manufacturing tools, specifically process variability reduction through standard work application. Measure performance and progress resulting from implementation of these tools.
Responsible for regular oral and written communication relating to progress and performance of work.
May lead or participate on project teams to complete special projects as assigned.
Provide input into annual capital budgets to provide operational improvement & risk mitigation.
Ensure that proper safety, procedures, and housekeeping are maintained.
- 3-5 year’s experience as a Process Engineer or similar function.
- Experience in Lean Manufacturing Tools such as Process Failure Mode Effects Analysis (FMEA) and formalized Problem Solving, required.
- Experience with Statistical Process Control implementation/management, required.
- Experience in a highly regulated environment, required. Medical industry experience, preferred.
- Lean Six Sigma Green or Black Belt Certification, preferred.
- Experience with Process Capability Analysis, preferred.
- Mini-Tab or JMP Statistical Knowledge, preferred.
- Formal project management experience, preferred.
- R&D Team
- Quality Team
- Operations/ Production Team
- Purchasing Team