Reporting to the Senior Director of Engineering, the Associate Director of Sustaining Engineering has the primary responsibility for evaluating, implementing and maintaining Genomic Health (GHI) Operational Engineering processes, tools and capabilities to ensure the installed base of equipment and instruments in GHI's state of the art Clinical Laboratory are maintained through their lifecycle, This includes equipment roll out to production, usage in the laboratory, implementation of necessary changes and retirement. The Associate Director will manage and lead these efforts, coaching and training teams that are working on these projects. He or she also will identify, measure and optimize key performance indicators on sustaining capabilities. This role is service-centric and requires close communications and collaboration with the Clinical Laboratory personnel, Quality Assurance, Service Engineering, Process Engineering, Process Validation, and other functions.The Associate Director will bring a passion for developing talent and teams to this role. He or she will manage the sustaining engineering team, including the recruitment of new members as necessary, the assignment of their responsibilities, the development of their skills, and the evaluation of their performance. This team-oriented leader will collaborate with various internal stakeholders and external vendors to ensure the process validation team operates with maximum effectivity in their roles.RESPONSIBILITIES / DUTIES:• Analyze sustaining, service and support processes and systems, and their interfaces to other functions, using various tools such as lean and gap analysis to define key performance indicators (KPI's) and use these to find opportunities for improvement.
• Manage the portfolio of service/sustaining engineering improvement projects, including prioritizing, scheduling and tracking, to provide and ensure timely and effective rollouts. Lead and/or coordinate key improvement projects with multi-functional team members, for improvement across the Operations organization. Collaborate with functional managers to achieve the desired results in a timely manner.
• Assess sustaining, service and support engineering capabilities within the Operations organization and propose strategies for improvements to help meet short- and long- term Operations and corporate goals.
• Recruit, manage and develop a team of sustaining engineers that will work closely with the clinical laboratory, service engineering, and other functions, as required.
• Maintain SOP's around the lifecycle of the installed base of equipment in the Clinical Laboratory.
• Incorporating practices such as Six Sigma and others, to reduce inefficiencies and improve quality.
• Monitor progress by establishing metrics and regularly generating detailed update reports for management.
• Establish partnerships with the Clinical Lab Operations, Quality Assurance and other departments and collaborate with them to confirm seamless integration of processes and procedures.
• Be the subject matter expert for sustaining, service and support processes and systems
• Mentor junior engineers by sharing guidance and technical expertise, coordinating workshops and team training, and ensuring resources for learning are readily available.
• Ensure sustaining. service and support engineering processes and workflows meet ISO 13485 and other applicable regulatory requirements.
A bachelor's degree in engineering or related field with at least 12 years of relevant experience including the management of a group
• Possesses an understanding of process improvement techniques and experience applying these techniques to make organizational changes
• Demonstrated expertise in the application of stand-alone equipment or integrated platforms in a highly automated laboratory environment.
• Experience and proficiency with project management best practices. Plans and executes stages of multiple projects. Organized and committed to meeting deadlines
• Coaches other team members to give their best effort and setting the direction for many initiatives
• At least 5 years of experience and strong proficiency in development of products and/or processes within the medical device or in-vitro diagnostic field, under ISO 13485 and/or FDA Quality System Requirements for medical devices
• Superb written and oral communication skills, and demonstrated excellence in communicating and collaborating with colleagues and customers from a wide variety of scientific, engineering, operational, and regulatory disciplines across the organization at many different levels
• Demonstrated ability to effectively lead and participate in cross-functional project teams
• Critical thinking skills required to judiciously plan and prioritize project activities for maximum leverage and impact
• Demonstrated leadership skills required to align colleagues and stakeholders around a vision and inspire team member to give their best efforts to achieve it
• Strong and consistent commitment to quality in generating and implementing workflows and processes for the laboratory.
• Ability to integrate and apply feedback in a professional manner
• Experience in the servicing of laboratory equipment including automated liquid handlers, RT-PCR, imaging systems and others.
• Desired: Experience in molecular biology, and the underlying chemistry of nucleic acid-based assays involving PCR, DNA sequencing, and related methods
• Desired: Certifications in continuous improvement methodologies such as Six Sigma, Lean or others.