Hardware Engineer

On QCDx

Precision cancer medicine depends on early cancer diagnosis, monitoring of treatment efficacy and surveillance for disease recurrence. QCDx LLC is an early-stage company who developed the RareScope™ instrument for precise detection and characterization of rare cells in bodily fluids. In cancer applications it detects different phenotypes of live circulating tumor cells (CTCs) and isolates CTCs for single-cell, molecular analysis from an immobilized cell suspension. It is also designed to allow perfusion with media containing bioactive substances (including drugs) with longitudinal visualization, to assess effects on target cells. The fully automated CTC liquid biopsy will deliver high throughput and assist the clinical oncologist in offering precision treatment that will improve both clinical outcomes and the patient's quality of life.

JOB SUMMARY

We are seeking a motivated Engineer to join our innovative team, contributing to the expansion of our high-resolution CTC detection platform powered by RareScope Technology. This position will be a key contributor in the design and development of our devices and driving quality management initiatives across the product development and manufacturing processes. You will collaborate with cross-functional teams in optics, biology and software to help bring our products to market.

ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES

Mechanical design, prototyping and documentation of components and subsystems of light-sheet microscope

Creation of detailed engineering drawings for fabrication and inspection using SolidWorks

Requesting quotes, placing orders, and interacting with vendors

Communicate progress to management and internal stake holders verbally, electronically and through meetings

Creation of Bills of Materials with cost information

Investigation of new technologies and industry trends for product design

Lead Design for Manufacturing efforts to decrease errors and assembly time of products

Support current and future programs through hands-on troubleshooting, ECO's, and prototyping

Assist in the development and implementation of systems and processes that foster continuous improvement for product development and/or manufacturing.

Ensure that all design control procedures have been followed and the records such as Device Master Records and Device History Records are maintained per ISO13485 and company requirements.

Write SOPs as required

Support the Material Review Board (MRB) for internal non-conformances and customer returns.

Lead or verify effectiveness of corrective and preventive actions (CAPAs).

Perform incoming inspections and produce supporting documentation as required

Education:

B.S. in an engineering degree discipline (Mechanical preferred)

Experience & Skills:

3+ years' experience in product design (medical device preferred)

Proficient in CAD software, preferably SolidWorks

Hands on experience in assembly of technical devices

Detailed drawing creation experience

Knowledge of machining, fabrication, and 3D printing practices

Experience with quality systems and tools (e.g., ISO 9001, SPC, FMEA, Six Sigma, root cause analysis). Experience in an ISO 13485 environment a plus

Experience with lasers and optics design a plus

Experience in fluorescent microscopy a plus

Project Management: Demonstrated ability to manage projects simultaneously while adhering to strict timelines in a dynamic environment.

MS Office– Excel, Word and PowerPoint. Familiarity with and able to work in MS Project.

Strong verbal and written communication skills, with the ability to effectively convey technical information to both technical and non-technical stakeholders.

Interdisciplinary Collaboration: Proven ability to work effectively in a cross-functional, interdisciplinary setting with diverse teams.

Candidates must be authorized to work permanently in the United States without sponsorship.

Training Requirements

General Safety, laser safety, laboratory safety

Quality System and Design Controls Training

Additional Information

QCDx is an innovative biotechnology company providing customers with superior research and development expertise since its inception in 2017. Our long-term success is a direct result of a strong commitment to the success of our employees.

We look forward to reviewing your application.

QCDx is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, or because he, she, them is an individual with a disability, protected veteran or other status protected by federal, and state laws.