We are looking for a senior Systems Engineer who is eager to roll up their sleeves, serve as a technical project lead and develop a device from concept to prototyping and eventual commercialization. You will work with biologists, engineers and outside contractors to develop overall system architecture and coordinate the design of hardware, software, and electrical systems for new laboratory instrumentation. This role will be involved throughout the entire product lifecycle from developing breadboards to verification, release to manufacturing and sustained support. . In addition to this, you will be expected to participate in key development activities such as system integration, reliability testing, root case analysis and failure mode investigation. The position ensures engineering designs meet established performance specifications and comply with applicable safety and regulatory certifications. It is necessary to ensure documentation practices are followed as well as validation and verification processes are complete.
Essential Duties and Responsibilities:
- Liaison with internal resources in the area of biology, marketing, manufacturing to co-develop detailed system architecture
- Interface with other engineering disciplines and outside contractors to define hardware and software specifications related to instrumentation functionality
- Oversee the testing of assembled instruments and analyze test results and develop strategies to improve performance, reliability and reduce cost. Develop and produce logs, procedures and reports on fabrication techniques and testing methods and results.
- Interface between external vendors and core team.
- Develop and implement validation and verification test documents and oversee testing and compliance of completed modules and systems to established procedures.
- Perform failure modes and effect analysis, FMEA on system and components and work with engineering staff to resolve any issues identified.
- May directly supervise or indirectly guide and mentor other engineers and technicians.
- May perform other related duties as required and/or assigned.
- Successfully apply expertise with safety procedures and regulatory agency compliance requirements (FDA/CE/TUV)
- Define hardware platforms that effectively meet performance, cost and project scheduling requirements
- Serve as technical/project management lead for engineering projects
- Act as a technical liaison for multiple cross-functional stakeholder teams such as engineering, quality, regulatory, supply chain, operations, top management, and the customer
- Requires a minimum of five years relevant engineering experience with an M.S. degree; at least 10 years’ experience with a B.S. degree.
- Proven problem solving and analytical skills.
- Hands-on prototyping skills. Experience with electronic and software design and breadboarding is ideal.
- Demonstrated track record of taking design from concept to production.
- Familiarity with hardware communication protocols including CAN, RS-485 and/or MODBUS
- Familiarity with software including C# and firmware including C, C++ and software platforms like MVVM
- Excellent problem-solving, design, development, and debugging skills.
- Ability to work on complex tasks with minimal technical guidance.
- Familiarity with CAD software such as Pro/Engineer or Solidworks.
- Background in development of complex biomedical instrumentation, specifically, molecular biology lab automation or processing equipment relating to oligonucleotide synthesis, assembly, modification, or detection is highly desirable.
- In-depth knowledge of fluid handling, robotics, microfluidics, and data analysis Familiarity with automation of laboratory processes also desirable.
- Excellent communications and analytical skills necessary.
- Familiarity with relevant safety regulatory requirements for laboratory instruments is required.
- Familiarity with a variety of instrumentation technologies including, multi-axis motion systems, microfluidics, pneumatics, thermal transfer and controls
- Bachelors or Master’s degree in Mechanical, Electrical or Software Engineering or related field.
- As a critical and essential role, the candidate must be willing and able to travel to the San Diego, CA office to report to work. We have protocols in place to provide a safe, socially distanced work environment.
- Ability to lift up to 15 pounds required
- Travel up to 30%