This is an R&D engineering position with an emphasis on the development and design of medical laboratory and diagnostic instruments. The successful candidate is expected to design and validate prototypes and instruments that integrates embedded software, mechanical, and electronic subsystems. The individual will work with a multidisciplinary team of scientists and researchers on the initial concept design, prototyping, product engineering, industrial design, verification, validation and documentation.
- Work with multidisciplinary R&D team members to establish and document design requirements and specifications for new laboratory, production process, diagnostic instrumentation
- Work with multidisciplinary R&D team members to design and develop prototypes
- Work and coordinate with components, engineering and design vendors and OEMs
- Establish, perform and document verification, validation and reliability test protocols
- Collect and analyze data, and generate reports
- Participate in technical reviews, risk assessment, DFMEA, DFM, DFA
- Lead development of protocols, fixtures and associated scripting/automation for test efforts
- Lead instrument, PCB, and firmware troubleshooting and issue resolution
- Provide support for the installation, verification, and maintenance of instruments at customer sites, laboratory or production site to ensure best-in-class service within established time frame
Qualifications and Skills:
- Experience with mechanical, electrical, control and/or embedded software system design
- Well-grounded in fundamental engineering design principles and test methods with demonstrated hands-on design competency working with complex medical instrumentation.
- Experience with complex laboratory or engineering test equipment, data acquisition systems, engineering design documentation, and calibration procedures
- Strong technical writing and communication skills
- Exceptional attention to detail
- Basic understanding in programming techniques (C/C++/Python) and/or script writing (using Labview, Arduino, PLCs, or similar)
- Strong troubleshooting skills
- Self-motivated and self-directed with the ability to schedule and work with little supervision
- Strong organizational skills
- Excellent interpersonal, collaborative, and leadership skills
- Statistical analysis skills are preferred
- Experience with end-to-end product development process for medical devices is preferred
- Knowledge of FDA QSR, specifically design controls, is preferred
- BS in Engineering or related field, or equivalent experience, plus 3+ years of relevant work experience.
- Preferred 2 or more years work experience designing and testing electro-mechanical systems, equipment and components for the medical device, biotechnology, pharmaceutical or diagnostics industry.
- Preferably with experience in microfluidic device development for analytical or diagnostics applications.
- Preferably with experience in rapid-prototyping technologies