Quality Lead

Job Description

A Day in the Life One of the key deliverables of UST is an electromechanical product that will be used in a clinical setting. We are looking for a senior mechanical engineer who will work on all mechanical engineering related technical activities; including engineering design/testing; quality/reliability assurance and manufacturability. Given the entrepreneurial nature of UST; this person will have to perform hands-on work in the mechanical/systems lab. Make verification strategy covering all the requirements; considering 1-to-1; 1-to-many and many-to-1 mapping of requirements and protocols Participate in efforts for ideation of physical manifestation of the product. This may include brainstorming of different concepts; rapid prototyping; selection of optimal solution(s); etc. Understand the system and each requirement; provide feedback on requirements in verification perspective Work with an interdisciplinary group of engineers (Systems; electronics; software and chemical) Strong understanding in concepts to be developed considering DFM; DFA; DFR; etc. Experience in design and development of text fixtures. Experience IEC standards Job Description of System Engineer Position Responsibilities: Ensure that device development meets targeted clinical application through systematic conversion of product requirements into systems solutions that meet technical; schedule and cost constraints Evaluate device use cases to define system requirements and evaluate technical tradeoffs Define Security and compliance requirements for the product; ensure system meets these requirements Participate/Lead risk assessments and develop mitigation plans to ensure safe operation of the product Participate in strategic discussions and own the technology development for the future generation of the product Manage; track and upgrade hardware and software configuration of system / sub-system set-ups in the labs Collaborate with quality and regulatory colleagues to ensure compliance with corporate; business unit and global standards applicable to the product Basic Qualifications: B.E. from reputed university in Mechanical / Electronics / Biomedical Engineering Atleast 1 year System engineering experience in the dialysis domain 5+ years in product development of complex electro-mechanical devices controlled by SW Knowledge of medical device quality and regulatory standards (ISO 13485; ISO 14791; IEC 60601; IEC 62304; etc.) Strong written and verbal communication skills; with attention to detail and thoroughness Able to work in direct; cross-functional and cross-cultural teams; with strong influencing skills Able to participate in late evening and/or early morning calls Self-starter; strong work ethic and initiative in accomplishing objectives; and delivering in ambiguous environments Desired/Preferred Qualifications: Working knowledge of define/collection of system requirements especially as applicable to healthcare sector Working knowledge of hardware and electromechanical engineering concepts (microprocessors/microcontrollers; wired/wireless communications; motors; sensors; valves; fluid circuits; etc.) Full product lifecycle experience (concept/prototyping; development; test; release; post-release) Knowledge of Agile methodology for software / product development Knowledge of creating automated testing infrastructure About UST Together; we can change healthcare worldwide. At UST; we push the limits of what technology; therapies and services can do to help alleviate pain; restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let s work together to address universal healthcare needs and improve patients lives.Help us shape the future. Whatever your specialty or ambitions; you can make a difference at UST - both in the lives of others and your career. Join us in our commitment to take healthcare Further; Together.,

Keyskills :
deliverysystem engineeringenvironmental impact assessmentcoachinguse casesdevice developmentcomplianceiec 62304calibrationiec 60601qualityagile methodologystatements of work sow