Job ScopeThe Process Engineer II will serve as a technical leader responsible for optimizing manufacturing processes, driving cost efficiency, enhancing quality, and supporting scalability through data-driven decision-making and cross-functional collaboration. This role will be a key contributor in advanced manufacturing support for Instrument Production, Quality Control, and Depot operations and will also serve as a subject matter expert in Lean methodology, validation, and continuous improvement.
Duties and Responsibilites- Lead and manage complex process improvement projects from concept through implementation.
- Identify process inefficiencies and drive measurable improvements with cost, quality, and throughput outcomes.
- Champion and mentor Lean and Six Sigma principles to improve process yield, equipment capacity, and factory capability.
- Author and maintain detailed Manufacturing Instructions, routings, and training documentation for advanced processes.
- Own and execute process validation protocols (IQ/OQ/PQ) with cross functional alignment.
- Analyze Value Stream Maps to identify opportunities for ongoing manufacturing optimization.
- Drive infrastructure expansion and production layout efficiency initiatives.
- Apply advanced Lean tools (e.g., DMAIC, Kaizen, PDCA) to engineer scalable and sustainable manufacturing processes.
- Design and optimize production cells and material flow to support high-volume and custom manufacturing needs.
- Utilize operational data to recommend and implement performance improving projects.
- Lead root cause investigations of manufacturing or field defects; develop corrective and preventive actions (CAPA).
- Establish and maintain standardized processes across teams and sites.
- Develop and train teams on best practices and SOPs to drive process consistency.
- Ensure compliance with all applicable environmental, safety, quality, and regulatory requirements.
- Use Statistical Process Control (SPC), DOE, scripting, and dashboards to monitor and reduce process variability.
- Lead creation and updates of FMEAs and Control Plans for key processes.
- Implement human error proofing strategies (Poka Yoke) in complex workflows.
- Optimize line balance, cycle time, and takt time to support lean operations.
- Develop and present ROI justifications to leadership for proposed capital or process improvements.
- Independently design and conduct Design of Experiments (DOE) for continuous and new product/process validation.
- Collaborate with production teams to resolve process issues and support operator efficiency.
- Lead identification and implementation of automation opportunities.
- Perform hands-on troubleshooting and process refinement as needed on the floor.
- Manage cross functional impacts of procedural, engineering, and documentation change releases.
- Analyze and implement Engineering Change Orders (ECO), Manufacturer Changes (MCO), and Departmental Changes (DCO).
- Act as liaison between departments to drive collaboration and alignment.
- Escalate complex or systemic issues to leadership proactively.
- Mentor junior engineers and provide technical guidance to cross functional peers.
- Other duties as assigned.
Education, Experience and Qualifications- Bachelor's Degree In Industrial, Manufacturing, Mechanical Engineering, or related technical field preferred
- Master's Degree In Engineering or related field preferred
- 5+ Years 5+ years of experience in process or manufacturing engineering in a regulated industry preferred
- 3+ Years 3+ years of experience in GMP/FDA regulated or ISO certified environment required
Training and Skills- High proficiency in Microsoft Office Suite (Word, Excel, Access, Visio, PowerPoint) (High proficiency)
- Excellent organizational, communication, and prioritization skills (High proficiency)
- Strong adaptability to fast changing environments and timelines (High proficiency)
- Deep expertise in statistical methods, SPC, and DOE (High proficiency)
- Advanced troubleshooting and data analysis using scripting, databases, and dashboards (High proficiency)
- Strong background in time studies, industrial engineering, and continuous improvement (High proficiency)
- Strong knowledge of cGMP, ISO, and FDA regulations (Medium proficiency)
- Proven ability to lead projects and work independently (Medium proficiency)
- Demonstrated ability to mentor others and foster cross functional collaboration (Medium proficiency)
Licenses and Certifications- Lean Six Sigma Black Belt preferred
- ASQ Certified Quality Engineer. preferred
Standard Working Conditions- Standard manufacturing and office environment - Constantly
Travel Requirements- 10% Potential travel for training, shadowing leading events
