Senior Engineer, Product Lifecycle

Position Summary:

The engineer is also accountable for supplier performance monitoring, tooling qualification, and the transfer and scale-up of manufacturing processes to external partners.

Position Responsibilities:

• Serve as the process owner for manufacturing processes at Contract Manufacturers for plastic cartridges, including but not limited to precision injection molding, laser welding, ultrasonic welding, mechanical assembly, and fluidic functional test.
• Define product specifications, process control indicator, test strategy, and supplier’s performance KPI for high volume disposable products.
• Accountable to resolve manufacturing issues related to yield, quality and throughput, in timely manner.
• Actively seek out for continuous improvement opportunities in yield, quality and cost.
• Collaborate with R&D, Manufacturing and Quality to develop molding and assembly processes for new products and improve processes of existing products.
• Lead technical and production teams to support pilot run and define scale-up manufacturing strategy at contract manufacturers.
• Candidate must thrive in a dynamic environment and place great emphasis on meeting milestones and breaking down barriers to achieve results.

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:

• Strong background in precision plastics molding and assembly processes required.
• Proven track record in managing Contract Manufacturing (CM) to resolve manufacturing & customer’s issues.
• Proficient in CAPA and structured problem-solving methodologies.
• Skilled in application of statistical tools including SPC, DOE and process capability analysis (PPK, CPK).
• Experience with product development lifecycle and project management required.
• Familiarity with the design and qualification of manufacturing jigs & fixture, equipment and automation solutions.
• Strong interdepartmental communication skills and documentation skills are required.
• Exposure to digital technology such as data analytics, RPA and AI applications.
• Willingness to travel for supplier engagement and technical support.

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 mechanical engineering, Bioengineering, Plastics Engineering, Materials Science, Chemical Engineering, or a related field.
• 5–9 years of relevant experience in biotech or medical device manufacturing.
• Proficiency in Solidworks or equivalent CAD tool.
• Experience in regulated environments (e.g. ISO 13485, GMP) is a plus.