Test Engineer

Coalesenz Inc. (Boston, MA) is an early stage, in vitro diagnostics company. We are developing a smart, multifunctional optical sensor that swiftly measures a patient’s blood coagulation status using a small sample of blood. This innovation is poised to address the unmet need to identify and manage patients with an elevated risk of life-threatening bleeding, a major cause of preventable death in hospitals.

Job description

Coalesenz is looking for a hands-on Test Engineer to support testing and development for device and consumable designs, company operations, and regulatory efforts. The Test Engineer will work hand-in-hand with the engineering team, technology inventors, software developers, clinical leaders and regulatory experts to deliver a quality life-saving product that is poised to improve patient care. This role offers the opportunity to drive innovation in microfluidics, optics, mechanical design, and electronics to build the next generation of blood coagulation testing devices.

The successful candidate: You are an Electrical, Biomedical or Mechanical engineer, with experience in medical device development and regulatory processes. You value team work, thrive in a collaborative, inclusive and diverse work environment. You are an innovative and creative problem-solver with an entrepreneurial mind-set.

Job responsibilities

• Work to develop and drive our novel in vitro diagnostic platform technology towards regulatory approval.
• Perform design, development and testing of novel technology for blood coagulation sensing to meet clinical requirements
• Work as a core member of the product development team and with all functional teams to coordinate activities.
• Develop and document test protocols to satisfy design requirements and product specifications and collaborate with in-house and external collaborators for verification/validation studies.
• Interface with strategic partners and corporate groups in addition to consultants, contractors and vendors.
• Assist in and coordinate product development and regulatory operations, reporting, documentation and grant preparation

Required Skills and Experience

• Bachelor’s or Masters degree in Electrical, Biomedical or Mechanical Engineering
• Proficiency in electronic and electrical circuits, soldering, Solidworks, machining (3D printing, laser cutting, welding, lathe etc).
• Wet lab experience including pipetting and solution handling
• Start-up experience or a strong desire to work in a start up environment is a plus
• Experience in engaging regulatory professionals for navigating the early stages of the product development process through FDA regulatory submission is a plus.
• Background and knowledge in medical device manufacturing is preferred.
• Proficiency in Matlab, Labview or Python is required. Familiarity in C/C , embedded C, etc is a plus
• Experience in 510(k) and/or PMA submission process for medical devices, is a plus.
• Demonstrated experience in the medical device industry, familiarity with product development procedures, design control documentation and FMEA, quality assurance and regulatory standards.
• Communicates ideas, information, and recommendations clearly, effectively, and frequently (oral and written).

*Coalesenz offers a competitive Benefits Package.

*Coalesenz is an equal opportunity employer.