Continuous Improvement Engineer - Exton, PA

Continuous Improvement Engineer - Exton, PA
You Will:
The Continuous Improvement Engineerwill be responsible for identifying and leading process improvement initiatives, cost saving projects, and the implementation/tracking of key Operational performance metrics on the Manufacturing floor as required to support both existing and new business within DSM Biomedical. This position will partner with key stakeholders across both Manufacturing & Quality departments tasked with improving current and future DSM Biomedical products/processes. This individual will provide Continuous Improvement support and mentoring across 3 manufacturing sites with primary focus and responsibilities at the Exton, PA facility. This position will play a critical role in driving Continuous Improvement culture and education, along with Lean Manufacturing methodology in operations throughout DSM Biomedical.
Responsibilities:

• Identify and optimize product/process variables required for maximizing performance (availability, output, yield); gather data and report on product/process performance.
• Manage risk, timelines, and stakeholders in the deployment of improvement projects
• Support Operations to address facility layout, equipment placement, resources, and start up milestones for flow optimization.
• Implement LEAN tools into operations to streamline processes and maximize value.
• Lead and facilitate Kaizens, Root-cause Investigations, Process Improvements Events as required to support business needs.
• Develop project plans, estimate project costs, operating costs, project schedules milestones, and resource requirements.
• Conduct and implement Continuous Improvement on projects/processes to achieve improvements in efficiency, productivity, yield and/or reduction in operating costs.
• Support, submit and execution of Management of Change (MOC) process.
• Following DSM Life Saving Rules (LSR), encourage fellow colleagues to work to the same standards.
• Execute the job within the applicable DSM, GMP, OSHA, EPA, ISO, FDA, CE, & other requirements.

We Bring:

• A competitive compensation package, with comprehensive health and welfare benefits.
• A place to grow and develop.
• A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
• The opportunity to work on growing brands and build on a strong foundation.
• The chance to make improvements and make an impact on the business.

You Bring:

• Bachelors or Master's degree in Engineering - Biomedical, Mechanical, Chemical, Materials, Electrical or related field.
• 3-8 years of experience in Medical Device or related industry.
• Experience with data mining of large, complex data sets and statistical analysis to understand the effect of processing variables.
• Knowledge and expertise of standards/products/processes manufactured and used in medical device environment; knowledge of physical, chemical and melt processing techniques (i.e. machining, injection molding, extrusion, sterilization) and manufacturing machinery and tooling.
• Knowledge and experience working with ISO 13485, 14971, 10993, and 21CFR Part 820 regulations;expertise working with Engineering & Quality tools (Statistics, Lean Six Sigma, DFM, DOE); experience leading root cause investigations with cross-functional teams.
• Six Sigma Green Belt certification or higher preferred.
• Experience with LEAN tools: 5S, Kaizen, VSM, PDSA, TPM, One Piece Flow, Poka-Yoke, Setup Time Reduction, Standard Work.
• Industrial scale hands-on experience with process optimization focus.
• Understanding of financial and accounting requirements in projects.
• Knowledge of manufacturing KPIs including: Run-rates, Cycle Times, Throughput, Yields.
• Proficient in the use of MS Office, Word, Excel, PowerPoint, MS Project, Minitab, and SharePoint.

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