Principal Process Engineer - OPEX
- Identify and Execute Continuous Improvement Projects: Lead the identification, evaluation, and implementation of continuous improvement projects across the manufacturing facility. This includes utilizing Lean Six Sigma tools and methodologies to analyze processes, identify bottlenecks, and develop solutions to optimize efficiency, reduce waste, and improve quality.
- Project Management: Develop project scopes, timelines, budgets, and resource allocation plans for continuous improvement projects. Manage project execution, track progress, and ensure projects are completed on time and within budget.
- Process & Automation Optimization: Develop and implement multiyear process improvements for existing manufacturing processes, including injection molding, assembly, and web conversion. This may involve optimizing equipment settings, developing new procedures, and implementing automation solutions.
- Data Analysis and Reporting: Collect and analyze production data, ownership and reporting KPIs such as scrap %, yield, and OEE
- Technical Expertise: Serve as a technical expert on assigned projects, providing process engineering support from concept through implementation. Provide detailed engineering specifications, feasibility studies, DOEs, and process‑flow diagrams; serve as SME during equipment FAT/SAT and start‑up.
- Team Leadership and Mentorship: Coach cross‑functional teams, champion a culture of CI, and mentor junior engineers and technicians.
- Regulatory and Validation – Lead or Support IQ/OQ/PQ activities, risk assessments, and documentation to ensure compliance to FDA, ISO13485, and internal QMS requirements.
- Bachelor's degree in engineering or related field preferred
- 4+ years of experience in a manufacturing environment with a strong focus on process improvement preferred
- Proven expertise in Lean Six Sigma methodologies (Black Belt certification preferred).
- Strong knowledge of Microsoft Project is preferred
- Experience with medical device process validation (IQ/OQ/PQ) preferred
- Experience with automated manufacturing systems, SolidWorks, and AutoCAD preferred
- Strong project management skills, with a track record of successfully leading and completing projects.
- Excellent analytical and problem-solving skills, with a data-driven approach to decision-making.
- Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
- Travel Expectations: 50%
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
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