Principal Systems Engineer
Position Title: Principal Systems Engineer
Position Type: Full Time
Job Type: Experienced
Reporting To/Department: Senior Vice President, Research and Development, Oncology
Lumicell is seeking a highly-motivated Senior Systems Engineer to work in a dynamic, fast-paced start-up environment. 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 system-level design, validation and commercialization of medical devices. Special consideration will be given to candidates with experience in product development, with preference for optical medical devices. The successful candidate is a self-initiating and independent problem solver who integrates well into existing company processes and helps promote the company’s collaborative culture.
The Senior Systems Engineer will be responsible for leading key aspects of the development of Lumicell’s flagship product in preparation for FDA approval and commercialization. Preference will also be given to candidates that have succeeded in driving projects through manufacturing transfer.
Essential Duties and Responsibilities:
- Apply a functional knowledge of systems engineering principles including many of the following topics: FMEA/Risk Analysis, Systems Architecture, System Integration, Requirements Management / Mapping, V&V Planning, Test Protocol Creation, Design and Test for Reliability and Robustness, FDA Design Controls execution, and compliance with ISO/ASTM/IEC standards.
- Own and maintain the Design Controls documentation package for our premiere in-development Class III device (combination Class II device with drug) for PMA submission.
- Own systems-level design and testing (while collaborating with technical owners and external suppliers / vendors) to ensure sound and thorough engineering.
- Lead the design team to complete risk analysis and perform design trade-offs for functionality, usability, cost, and risk. These trade-offs also need to be weighed against input from key internal and external company stakeholders.
- Lead transition of mature design through pilot build and into contract manufacturing
- Develop strategy for verification and validation testing in accordance with FDA guidelines.
Generate and develop new tests and methods, write and execute test protocols, write reports, and generate intellectual property.
Contribute to technical investigations of our clinical trial device via: identifying root cause, conducting investigational test protocols, implementing corrective actions, and developing investigational reports.
Education and Required Experience:
- Bachelors with 5-10 years experience or Masters with 10+ years experience in Engineering field (Biomedical, Mechanical, Electrical).
- Ability to drive a medical device product through development and lifecycle milestones
- Strong understanding and execution of medical device design controls.
- Experience with Helix ALM or equivalent requirements management tool is highly desired.
High proficiency with Solidworks and EPDM required
Familiarity with Microsoft Project or other equivalent productivity tool required
- Experience with data analysis tools such as Matlab, Python, or ImageJ required
- Familiarity with 21 CFR 820, ISO 13485, IEC 60601 and IEC 62304 is highly desired.
Experience with medical imaging, fluorescence imaging and/or optoelectronics is highly desired
Critical Competencies for Success
Excellent problem-solving, troubleshooting, and 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 over other managers.
- This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones
- This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones.
- Lumicell has an implemented and strictly enforced COVID Policy that’s intended to keep all employees safe when working on-site. Our policy mandates: restricted number of employees on-site at a time, a socially distanced and protected seating structure, mandatory mask-wearing, and daily cleaning & disinfection of all communal areas.
- Employees are given full flexibility to be able to work on-site and remotely in order to help limit the amount of person-to-person exposure. On-site vs. remote working percentages will depend on the individual’s responsibilities and project needs.
- Lumicell has also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.
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.