Jobs for People with MS: National MS Society

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Responsibilities and duties

• Conduct Risk Management per ISO14971 to ensure the safety and effectiveness of product.

• Conduct design reviews & risk management reviews as required during various project phases.

• Work with R&D during Electrical/ Embedded developments (Electrical & electronic hardware development and Software development) to provide inputs w.r.t quality & safety.

• Participate and conduct DHF / DMR Reviews for Software / Electrical/ Embedded developments.

• Support Computer System Validations & Process Validation as required.

• Support in conducting cybersecurity risk assessment documents.

• Support in V&V to ensure product compliance, safety, reliability & effectiveness.

• Review of Clinical Evaluation Reports, Post Market Clinical Follow up & Safety documentation and Regulatory documentation on Quality aspect.

Experience/skills required.

• Practical implementation of Risk Management of Medical Device per ISO 14971.

• Experience with Risk Analysis tools and techniques.

• Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304.

• Experience on Medical Device Electrical/Electronic Hardware Development Life Cycle Process (HDLC).

• Understanding of various documentation required during Hardware & Software development lifecycle.

• Understanding of electrical & embedded component’s working principle and functionality.

• Familiarity with IEC 60601-1 family of standards.

• Familiarity with any basic programming language, embedded software & tools.

• Understanding of Quality Management Systems for Medical Devices. (ISO 13485, 21 CRF 820).

Education

• B. Tech / B.E / M. Tech / M.S. – Software/ Electrical/ Embedded Engineering

• Experience: 4-8 years

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.