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Project Engineer
2 months ago
Job Description: Project Engineer
Duration: 12 Months on W2 - No C2C
The Engineering Project Manager is responsible for overseeing complex engineering initiatives, including business development projects, new machinery installations, machinery and systems upgrades, and collaboration with corporate IT on critical IT infrastructure projects. The role involves leading the validation and qualification of new products, processes, machinery, and systems, while continuously identifying process improvement opportunities using Lean Six Sigma methodologies. The manager will also handle the management, updates, and qualifications related to production and process changes.
Key Responsibilities:
- Effectively manage engineering projects, ensuring project scope, deadlines, costs, and implementation meet Company and International Standards.
- Write and execute detailed validation protocols for FAT, IQ, OQ, and PQ.
- Evaluate manufacturing processes by conducting research, applying product design and testing knowledge, and collaborating with equipment vendors and operators.
- Develop and optimize manufacturing processes by studying product requirements, researching, designing, modifying, and testing methods and equipment.
- Assure product and process quality by designing testing methods, validating finished product and process capabilities, and establishing and confirming manufacturing standards.
- Provide decision-making information by calculating production, labor, and material costs.
- Prepare product and process reports by collecting, analyzing, and summarizing data and trends.
- Solve product, process, and system-related problems using Six Sigma tools, DoE, FMEA, and process risk assessments.
- Conduct technical evaluations and cost assessments to recommend process improvements.
- Collaborate with Corporate IT on infrastructure projects.
- Manage relationships and expectations with internal and external stakeholders to ensure smooth project delivery, taking contingency actions when necessary.
Requirements:
- Bachelor’s degree in Engineering is required.
- A minimum of 10 years of experience, with 5-7 years in an engineering role within medical device manufacturing.
- Demonstrated commitment to continuous improvement, with familiarity in Kaizen, 5S, and value stream mapping; Lean Six Sigma certification is preferred.
- Strong knowledge of manufacturing processes, methodologies, and technologies, along with lean manufacturing principles, Six Sigma, and quality management systems.
- Proficiency in project management, including planning, scheduling, budgeting, and resource management, with experience in project management software being advantageous.
- Strong analytical and problem-solving skills with the ability to identify root causes and develop innovative solutions.
- Excellent communication skills, with the ability to present technical information clearly and collaborate with cross-functional teams and external suppliers.
- Knowledge of quality management systems and regulatory compliance, including ISO standards and regulatory frameworks applicable to the industry.