Position Summary

As a member of the team, you will be part of defining, developing, implementing, and transitioning new technology solutions to design teams and manufacturing to increase efficiency, reduce cost, improve quality and deliver customer value. This role provides project and supplier management and oversight responsibilities to support engineering and manufacturing product development and implementation. You will facilitate timely and targeted manufacturing and supply chain capabilities, product feature enablers, and technology process capability that meet or exceed the needs of our customers. It will involve interfacing with internal and external customers,  engineering disciplines and  manufacturing . In addition, the role will require the ability to handle multiple projects concurrently in a dynamic/fast-paced work environment.

Responsibilities include but are not limited to:

• Develop plan and execution for scaling and ramping production of a molecular diagnostic Reader.
• Mid volume manufacturing 500 to 2K month and experience with plastics, electro-mechanical assembly, fluidics and optics is a must have.
• Experience in virtual team management and offshore coordination
• Experience in medical device manufacturing process, process flow and process mapping, quality system, validation and risk assessment
• Experience in technical documentation / business case / change order – writing, reviewing and routing documentation
• Experience in packaging processes and value chain analysis
• Knowledge in sterility assurance / microbiology, verification / validation, assessment of risk and mitigation plans
• Knowledge in product life cycle management, NPI / NPD, and cGxP
• Knowledge in EU-MDR, FDA CFR Title 21, ISO 13485:2016 and understanding of regulatory requirements
• Experience in formulating WBS, creation of work packets and structuring the scope at project level
• Excellent communication and stakeholder management
• Excellent team player with leadership skills
• Guide team members to perform through issues and constraints
• Own the timeline, budget, resource constraints, and deliverables / results
• Ensure all appropriate tools are completed and used effectively (e.g., charter, Gantt chart, status updates)
• Actively communicate with project sponsors, vendors and stakeholders
• Perform root cause analysis on project shortfalls and takes corrective action as necessary
• Identify root causes of issues and design solutions that address them
• Defining, monitoring, and controlling processes
• Understanding (internal/ external) customer needs and designing solutions around them
• Identifying the impacts from change and developing proactive change plans
• Assist in accurately forecasting, planning, reporting and managing throughout the project
• Proactive management and resolution to issues to minimize crisis and escalations, and proactively informing and engaging Senior Management in advance when issues cannot be avoided.

Necessary Education and Skills

• Bachelor’s degree with 7-10 years
• Preferred: Previous experience with the healthcare and diagnostic arenas.
• 5 years + technical development experience, preferably in Medical instruments and consumables.
• Experience working closely with contract manufactures.
• Experience in continuous improvement and leading change
• Demonstrated ability to develop strong relationships with others
• Ability to handle multiple projects simultaneously