Position Overview
The Senior Manager, R&D Automation Engineering is a key problem solver and a potential 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 understanding of advanced engineering principles, advanced engineering methods, data, and judgment to influence the course of product development activities. 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 Senior 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. This position will utilize technical skills, with 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.
Essential Duties
Include, but are not limited to, the following:
- Develop automated laboratory solutions to meet the requirements of existing assay workflows.
- Iteratively design, develop, and implement automated liquid handler methods for use in a high throughput 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) and 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.
- Supervise staff; including, but not limited to, organizing and prioritizing work, writing/conducting performance reviews, training/developing, and managing work performance.
- Communicate goals clearly to employees to ensure understanding and success in achieving them.
- Motivate and inspire employees to do their best work through coaching.
- Maintain morale and support employee engagement initiatives.
- 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.
- 8+ 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.
- 10+ years of relevant experience in product development.
- 8+ years of experience working with automated liquid handlers and associated software in a regulated environment (CLIA, CAP, ISO, etc.). Experience with Hamilton liquid handlers is preferred.
- 6+ years of experience with requirements development and risk management.
- 5+ years of experience with ISO requirements and GMP guidelines, FDA regulations, and design control.
- 2+ years of experience developing software solutions in Python, Java, C# or other programming language.
- High attention to detail and proven ability to effectively communicate across teams located at multiple sites.
- Proven ability to troubleshoot technical issues in collaboration with a team of scientists.
- Experience working in a fast-paced environment with changing priorities and demands.
- Familiarity with Next-Generation sequencing and/or common molecular biology laboratory workflows.