Principal Biomedical Engineer
Position Summary
TellBio is seeking a Principal Biomedical Engineer to support TellDx, the company’s proprietary, microfluidic diagnostics platform that detects circulating tumor cells (CTCs). Reporting to the SVP, Head of Operations, this hands-on position is responsible for all engineering activities from oversight of system enhancement(s) through system verification and validation. This Director level position will be responsible for the development and qualification of system-level product requirements that integrate instrumentation, fluid handling systems, reagents, and consumables into a high-quality product. Additionally, this individual will work with contract manufacturer, consultants, and scientific founders to establish a robust TellDx training curriculum and provide technical support both internally and externally. Knowledge and demonstrated expertise in multi-tasking, problem solving, risk management, technical trade-off analysis and decision-making is required. Knowledge of software development processes in the context of system control and fault detection is also required. A working understanding of design controls and regulations relating to medical device product development and manufacturing transfer is strongly desired.
Roles/Responsibilities
- Lead strategic and operational advancement of TellDx platform including system-level leadership and support
- Optimize enhancements, testing and validation efforts for TellDx platform including large scale manufacturing of CTC Isolator and CTC iChip
- Manage TellDx supply chain manufacturers and contracts
- Work across development and manufacturing disciplines in establishing appropriate design verification test methods and statistically sound protocols for TellDx platform
- Ensure alignment of TellDx manufacturing activities and resources with scheduled activities and deliverables
- Work directly with contract development firms to enable meeting product requirements, as well as execute verification and validation test plans
- Timely communication of quantifiable issues and proposed technical solutions to executive management
- Establish TellDx training + support programs for the Company and its customers prior to and during implementation of the platform
- Provide in-depth knowledge and guidance with respect to regulations and standards system safety and usability
Requirements
- MS or PhD in Biomedical or Mechanical Engineering with at least 5 years of medical device development and testing experience
- Experience developing and guiding execution of Reliability Engineering test requirements, plans and methodologies for instrumentation platforms and systems incorporating consumables/disposables
- Commendable track record of technical acumen and remarkable emotional intelligence
- Experience as a key player on a team that has taken a device, diagnostic tool through regulatory clearance and commercialization
- Experience in building, mentoring, motivating, and developing incredible engineering support teams
- Excellent verbal and written communication and organizational skills with demonstrated success in leading projects and inspiring cross functional teams
- Proven ability to anticipate, navigate, creatively problem-solve, and lead in a dynamic and fast-paced environment
- Embodies patient centricity, rational risk-taking, integrity, grit, and mutual trust for team members
Our Company
TellBio is an integrated diagnostics and therapeutics platform company focused on eradicating cancer metastasis. Founded in 2019, TellBio is a private, early-stage biotechnology company headquartered in Beverley, MA. Our mission and purpose is to free patients from the tyranny of cancer.
We are an equal opportunity employer offering competitive salary and benefits. All applicants should be legally entitled to work for any employer in the US.
Potential Candidates: Please send cover letter + CV to info@tellbio.com and include the position of interest in the subject line of your email.
Recruiters: Kindly do not submit any CVs. TellBio will not be responsible for any fees related to resumes that are unsolicited.