Position Summary:
Product Lifecycle Engineer serves an important role in ensuring that the product is transferred, manufactured and delivered at the utmost quality to the customer. The individual will interact extensively with other departments such as manufacturing, equipment, quality assurance, R&D, supply chain and facilities, to sustain and improve processes for existing products.
Position Responsibilities:
- Analyzes production and field quality data, to ensure Safety, Availability, Quality, Cost and Compliance targets for process and products are met.
- Perform troubleshooting, failure analysis, root cause identification and provide optimized preventive or corrective actions for line issues related to yield, process and quality of product.
- Constructs and executes controlled experiments to address production and quality issues and drives implementation of solutions to meet operation goals
- Proactively drives process improvement activities through engineering problem solving methodology (8D, DOE, FMEA, Ishikawa, Six Sigma etc) to ascertain and recommend improvement to processes or test methods.
- Lead or support improvement projects and drives change management associated to implementation of identified deliverables.
- Ensure process system and equipment are compliant to company quality system and regulatory requirements.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
- Possess good understanding of manufacturing process, methodologies and environment.
- Capable of defining test plans for components, materials and systems
- Skilled in failure analysis of multiple reliability failure modes
- Excellent Analytical, Problem Solving and Project Management skills.
- Good understanding of Quality Assurance and Process Control Knowledge.
- Excellent team player, interpersonal and communication skill.
- Able to work well under stress, both internally and across functions and perform multitasking.
- Proactive, innovative and self-motivating.
- Able to work in manufacturing environment where there might be possible exposure to loud noise.
- Able to identify components with different colors (using visual)
Competencies:
- Core Technical Leadership
Demonstrates leadership in the development of technical innovations and in ensuring optimum collaboration and knowledge sharing of technical insights.
- Project Leadership & Troubleshooting
Actively works to resolve project challenges and facilitate knowledge transfer between team members focused on shared objectives.
- Technical Breadth/Depth
Demonstrates motivation to build deeper technical depth in area-of-expertise and inform that knowledge base through understanding of associated areas.
- Customer-Centric Focus
Ensures that a positive customer experience informs both the approach to work, the quality demonstrated, and the endpoint for measuring success.
- Thought Leadership
Understands how businesses operate and uses this context to drive innovation and ethical decision-making.
- Change Management
Develops methods for supporting innovation and change across the
organization.
- Problem Solving
Approaches problems in a rational manner using sound strategies that ensure comprehensive understanding and effective resolution.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:
- Bachelor's Degree in Engineering/Science in Chemical, Biomedical or Material.
- Min 1-3 years of work experience in biotech or medical device industries is strongly preferred.
- Experience in FDA-regulated environment is a plus.
