Pls share Candidates from Medical Devices Testing companies.
Job Description:
- Overall technical leadership and responsibility for realization of a new product release and sustaining activity.
- Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
- Systems design/architecture and Integration oversight.
- Support for NPI efforts that create value for Clinical Applications and Devices Organization through innovation and design, while delivering high quality engineering solutions.
- Technical liaison to the program
- Defect/Risk management and Design Reviews
You are a part of:
A team of highly skilled engineers that is focused on creating world class health care solutions. Our focus on improving lives contributes to our amazing work environment and culture.
To succeed in this role, you should have the following skills and experience:
- BS degree in engineering
- Experience leading medical, or other regulated industry, product development
- Experience in leading groups to solutions for complex problems
- Experience with deriving and simulating human interactions with devices and device use conditions
- Experience with electronic requirement data management SW – preferably DOORS
- Minimum five years engineering / R&D experience in a rigorous quality-focused environment
- Minimum three years’ experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines
- Excellent requirements and specification writing skills
- Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product
- Ability to build and maintain effective cross-functional and cross-organizational relationships
- Excellent oral, written and presentation skills
- In depth knowledge performing risk management per ISO 14971
- In depth knowledge in developing and testing products to IEC60601-1 Safety standard
- In depth knowledge in developing and testing products to IEC62336 EMC standard
Preferred Requirements
- Understanding of US and international regulatory requirements for medical devices strongly preferred
- Experience developing reliability plans
- Knowledge of product development processes and best practices
- Knowledge of verification and validation testing processes
- Electrical or Software development experience is a plus
- Master’s degree preferred
Skills Required
- BS degree in engineering
- Minimum five years engineering/R&D experience in quality-focused environment
- Minimum three years experience in a Systems Engineering role
- Excellent requirements and specification writing skills
- In depth knowledge performing risk management per ISO 14971
- In depth knowledge in developing/testing products to IEC60601-1 and IEC62336 standards
What We Do
We started the organization with a vision of some of the top technology professionals in the industry to carve a niche for the next generation solutions as well provide that breeze of fresh air in emerging technology which will help our client think out of the box and provide rapid go to market solutions . The complex technology solutions and global multilingual programs roll out have been hall mark of success for our team. Our key team members are all hands on professional who have the vision and experience of having grown and developed the business from scratch. The have been the guiding power and light behind taking the company to the next level. The management of the organization has an average of over 20 years of experience in starting and running IT companies in the J2EE segment and ERP segment in North America , Australia , EMEA and Europe. The management actively guides the company to make strategic decisions and move forward and make the right decisions . We provide path breaking solutions and consultants who will fit, meet and exceed your requirements. Our focus is primarily in SAP, Oracle, IBM and MS technologies with expertise in technology verticals like cloud, big data and mobility. SAPSOL Technologies Inc . is currently funded by private investment from our management and some external investors. We are open to innovative proposals as well as funding the next generation of solutions for other start-up companies who have a great idea but are unable to leverage
