Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
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.
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.
What You will do:
Responsibilities and duties
Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review,.
Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
Participate in design reviews during various phases of NPD or Remediation for EU MDR.
Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
What You Need:
Required skills:
Bachelors in Mechanical/Biomedical/Biotech Engineering.
Good analytical and problem-solving skills.
Basic Knowledge of EU MDR.
Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
3-7 years of relevant work experience.
Experience on NPD process and various phases of new product development.
Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards
Expert-level knowledge of current industry standards for New Product Development and risk management practices.
Preferred Skills:
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.
