Position Title: Research and Development (R&D) Engineer
Position Type: Full Time
Job Type: Entry Level
Reporting To/Department: Senior Vice President, Research & Development, Oncology
Lumicell is seeking a highly motivated R&D Engineer to work in a dynamic, fast-paced start-up environment on a combination drug-device product. Lumicell is developing a breakthrough surgical guidance technology platform consisting of a proprietary drug that is activated by the micro-environment of cancerous tumors, a custom fluoroscope that allows a surgeon to visualize activated drug, and a software system that gives a real-time prediction of tissue likely to be cancerous. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its early development.
The successful candidate must have a proven track-record in finding and fixing bugs in complex systems and recording test results in support of engineering product development and continuous improvement initiatives; interests, coursework, or project experience in medical imaging and optics is also desired. The successful candidate is a self-initiating and independent problem solver who integrates well into existing company processes while adapting to new roles as necessary and can gradually take on increased responsibility and project ownership.
The R&D Engineer will be an integral part of the Product Development team and will monitor, maintain, and improve the quality and performance of Lumicell’s medical device products through manufactured device and sub-system performance testing, troubleshooting issues with fielded systems, maintaining design history files, and implementing design improvements to address user and/or business needs.
Essential Duties and Responsibilities:
- Lead hardware sustaining activities through initiating, investigating, and closing out non-conformance reports (NCR’s)
- Analyze the design and functionality of prototype hardware and software systems, assist team in enhancing existing systems in lab or field environment to ensure product reliability and usability
- Create detailed Design of Experiments (DOE) to identify sources of variation in products and processes, and support root cause failure analysis
- Plan and execute design verification and design validations based on existing or modified specifications and standards
- Participate in Risk Management activities including, Fault Tree Analysis, Usability Evaluation, and Failure Mode and Effects Analysis activities to ensure process shortcomings are identified and appropriately addressed
- Initiate and review documentation in compliance with Lumicell’s Quality System and Design Control Procedure
- Show exceptional attention to detail and ability to effectively and accurately document test results
- Confidently communicate and present findings to the team, other engineering disciplines, and senior management
Work includes prototyping, bench top test development, risk assessments, clinical studies, and extensive collaboration with internal and external partners and key opinion leaders
- BS in Biomedical, Mechanical, or Electrical Engineering or related discipline
- 1-3 years of experience in the medical device field with a product development or reliability focus in a regulated environment (510k, PMA) preferred.
- Experience evaluating the performance of complex hardware systems through manipulation and assessment of the acquired data
- Experience with medical imaging, fluorescence imaging and/or optoelectronics preferred
- Familiarity with 21 CFR 820, ISO 13485, IEC 60601 and IEC 62304 preferred
Critical Competencies for Success
- Excellent problem-solving, troubleshooting, written and spoken communication skills
- Detail-oriented and highly organized
- Must be able to work independently and as part of a team, learn quickly, and take on responsibilities outside of this scope of work, as necessary
- Must have strong patient and user focus and design with patient outcomes in mind
- Must be resilient and focused with a knack for navigating complex and occasionally ambiguous environment
- This position does not currently have supervisory responsibilities.
- This job operates in a professional office/ laboratory environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones, as well as various hand tools, microscopes, metrology equipment, etc.
Position Type/Expected Hours of Work
- This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
- Some travel may be expected for this position including internal meetings, conference and or training events.
- Lumicell is an equal opportunity employer
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice
To apply for this position, please send your resume to firstname.lastname@example.org.