Led design & development/sustenance of Class II/III medical devices (electromechanical, disposable, implantable). Managed Design History Files (DHF) and ensured compliance with ISO 13485 , IEC 60601 , FDA & EU MDR . Led risk management (ISO 14971) activities including FMEA (Design & Process) and hazard analysis. Developed design inputs/outputs, V&V plans , test protocols, and technical reports. Collaborated with cross-functional teams (QA, RA, Manufacturing, Supply Chain, Clinical) for design transfer . Conducted design reviews to ensure safety, reliability, and manufacturability. Executed test method & process validations ; supported FEA coordination for design analysis. Contributed to regulatory submissions (510(k), CE Mark, MDR) with technical documentation. Led engineering change management using electronic change control systems. Supported process improvement initiatives in product development lifecycle. Preferred candidate profile Proven experience in design, development, and design sustenance of medical devices. Strong knowledge of FDA 21 CFR Part 820 , EU MDR , and ISO standards (ISO 13485, ISO 14971). Hands-on expertise in risk management using tools like DFMEA , aligned with ISO 14971 . Skilled in preparing and remediating Design History Files (DHF) and authoring technical documents such as test protocols/reports and risk management reports. Experienced in identifying and executing verification and validation (V&V) requirements. Knowledge of test method validation , process validation , and design change management . Proficient in tolerancing (GD&T) and tolerance stack-up analysis (statistical and worst-case). Familiar with Design for Six Sigma (DFSS) , statistical methods , and Design of Experiments (DoE) . Strong grasp of design controls , biocompatibility (ISO 10993) , usability (IEC 62366) , and electrical safety (IEC 60601) . Understanding of Software as a Medical Device (SaMD) considerations.
Note : Please send a 2-minute self-introduction video highlighting your skills and areas of interest while applying for this job. Send the video (or link) with your resume to: info_upshot@upshotengineering.com Applications without video will not be considered. Role & responsibilities Preferred candidate profile Learn and understand medical device construction, design, and operation through guided training and mentorship. Familiarize with international standards relevant to medical devices and biomedical systems. Support the team in preparing and maintaining technical and regulatory documentation. Collaborate with cross-functional teams to assist in delivering engineering outputs. Participate in research, benchmarking, and feasibility studies under supervision. Take part in knowledge-sharing sessions and training programs to develop core technical and regulatory skills.