Position Overview
The Manager, R&D Automation Engineering is a key problem solver and a core team leader to plan and lead cross-functional product development projects for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. This position will use expert technical skills, conceive, plan and lead R&D product development activities to achieve project goals. This position will leverage an understanding of advanced engineering principles, advanced engineering methods, data, and judgment to influence the course of product development activities. This position will lead a team of engineers and advocate best practices for process and systems development, ensure appropriate team member training, and identify continuous improvement opportunities.
Beginning with analysis of the business process requirements, these process design and integration efforts will encompass the generation and collection of requirements, design and architecture, incorporation of applicable automation technologies, integration of multiple subsystems, and end-to-end testing. This position provides clear leadership to the team by working to define clear and realistic goals, clearing barriers to success, developing a general management view of the project and how it fits into the strategic landscape, and understanding of all the skills and tasks associated with successful project execution which are complex in scope.
The Manager, R&D Automation Engineering will develop and deploy robust laboratory automation solutions for Next-Generation Sequencing based assays in support of high complexity laboratory developed tests and In Vitro Diagnostics. This position will utilize critical problem solving, technical skills, with limited oversight, to participate in conceiving, planning, and executing research and development activities to achieve project goals. The successful candidate has experience working in a collaborative, fast-paced team to build scalable, highly integrated automation platforms which enable users to reliably and efficiently deliver timely, high-quality results in a regulated environment.
This is an onsite position at our San Diego location.
Essential Duties
- Lead and develop automated laboratory solutions to meet the requirements of existing next generation sequencing assay workflows and assay workflows in development.
- Iteratively design, develop, and implement automated liquid handler methods for use in a high throughout environment, improve methods based on feedback from experimental data and user feedback.
- Support accurate and robust automation software integration with external systems (LIMS, integrated hardware, etc.) through the development of Installation and Operational Qualification procedures.
- Support design transfer and deployment of automation solutions across multiple sites which meet product requirements and are fully integrated with clinical laboratory workflows.
- Train, guide and mentor junior level engineers.
- Assist and train laboratory personnel on the use of automated systems.
- Maintain and troubleshoot automated systems and processes.
- Participate in new product design and design improvements to existing products.
- Collaborate with cross-functional teams to ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.
- Lead Human Factors Engineering/Usability Engineering tasks and activities.
- Lead product risk management activities involving system Hazard Analysis (HA) Failure Modes and Effects Analysis (FMEA).
- Collaborate with Quality team to establish templates and processes for the documentation of systems engineering tasks and activities.
- Participate in the definition of key development deliverables, milestones, dependencies, risks, and mitigations as part of the Integrated Program Plan.
- Establish interfaces across other organizational groups.
- Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assessing employee performance and providing helpful feedback and training opportunities.
- Consistent demonstration of exceptional leadership qualities, including, but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
- Apply strong analytical and problem-solving skills.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to lift up to 20 pounds for approximately 5% of a typical working day.
- Ability to comply with any applicable personal protective equipment requirements.
- May perform repetitious actions using lab tools.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- Bachelor’s Degree in Engineering or field as outlined in the essential duties.
- 10+ years of relevant experience in product development.
- 6+ years of experience working on projects with cross-functional technical teams through a formal phase gate or new product development process.
- Demonstrated ability to hire, lead, develop and train direct reports effectively.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Preferred Qualifications
- Advanced degree (Masters/PhD) in Life Sciences or related field as outlined in the essential duties.
- Demonstrated Hamilton Venus programming experience.
- Demonstrated experience in successfully automating Next-Generation Sequencing library preparation assays on Hamilton liquid handlers from feasibility to product launch.
