Engineer – I Assembly and Testing

Job description Qualifications – Engineer – I Assembly and Testing - At a minimum - Bachelors in Engineering (Electrical, Mechanical or Biomedical). - Proficient in MATLAB. Familiar with image analysis toolbox (preferred) (other programming language familiarity will be considered?) - Solidworks (working knowledge - preferred). - Prior research experience preferred. Responsibilities – Engineer – I Assembly and Testing Assembly: - Collaborate with Medical Device Assembler I to ensure all items required for assembly are ready (including but not limited to – raw material, cleaned components, sterile pouches, all materials inside clean room and clean room are cleaned). - Assemble RM Electrode (all SKUs). - Work with Operations Lead and Assembly Team to sterilize and store RM Electrode Canine. - Work with Operations Lead and Assembly Team to ship and receive RM Electrode pre and post sterilization. Collaborate with Quality whenever required. - Whenever required, collaborate with Medical Device Assembler I to manage inventory (assigned/determine by Operations Lead). Receiving and Incoming Inspection: - Handle incoming shipments for critical and non-critical components assigned to you (TBD). - Follow work-instructions to perform incoming inspection of critical and non-critical components assigned to you (TBD). - Work with Quality Manager to report non-conformances. - Collaborate with Operations Lead and Quality Manager to ensure due process is followed and all stakeholders are in the loop. Optical Quality System: - Work with CTO and Scientist to design and develop Optical Quality System software. - Work with Scientist to build and maintain code documentation (for e.g., process documentation, developer documentation, walkthrough documentation for internal use and README files, usage documentation and user guides for external use). - Periodically review software to keep it up to date with relevant MATLAB versions. - Work with CTO to improve Optical Quality System hardware. - Work with Quality to write work instructions (separate from code documentation). Testing (including but is not limited to – usability testing, performance testing, functional testing, compliance testing): - Participate in testing activities whenever required. - Follow good documentation practices and good laboratory practices. - Work with CTO and Scientist to design new testing protocols whenever required. - Work with CTO to develop test set up (e.g., developing CAD models, researching for appropriate test equipment required for test set up). - Analyze and summarize data whenever required. - Work with Engineering and Quality Team to periodically (determined by CTO) calibrate test equipment. Clinical trials: - Participate in testing activities whenever required. - Follow good documentation practices and good laboratory practices. - Work with CTO and Scientist to design new testing protocols whenever required. - Work with CTO to develop test set up (e.g., developing CAD models, researching for appropriate test equipment required for test set up). - Analyze and summarize data whenever required. - Work with Engineering and Quality Team to periodically (determined by CTO) calibrate test equipment. Quality and Quality Requirements: - Quality Management System – GreenLight Guru. - Adhere to RetMap’s quality standards and requirements. - Follow established work instructions and procedures to perform required tasks (including but not limited to cleaning of critical components, assembly, storage and handling). - Follow due process to incorporate any changes in established work instructions. - Whenever required, draft work instructions. Review with Operations Lead to ensure process is accurate, and work with Quality to finalize and upload into Quality Management System (QMS). Quality Policy: To confirm our commitment to meeting the quality standards required by our customers and the regulatory bodies in the delivery of the medical devices manufactured by us. Quality standards are maintained by adhering to RetMap’s three core principles: - Attention to detail. - Consistency. - Collaboration. Code of Conduct: - Bias for thoughtful and strategic action - Knowledge guided agility – Our goal is to be nimble and to adapt quickly to challenging situations or change that will benefit our customers, patients, and company. Although the goal is to adapt quickly, adaptation must occur with deep knowledge of process and consequences, along with strong reasoning. Job Type: Full-time Pay: $22.00 - $24.00 per hour Expected hours: 30 – 40 per week Benefits: 401(k) Health insurance Paid time off Schedule: 10 hour shift 12 hour shift 8 hour shift Day shift Evening shift Education: Bachelor's (Required) Ability to Commute: Chicago, IL 60642 (Required) Work Location: In person