At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team
Who we want:
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
- Delivers results. A driven player who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks
What you will do:
- Primarily responsible for: Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER.
- Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
- Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.
- Participate in design reviews during various phases of NPD.
- AQE should drive coordination with different departments (such a R&D, BML, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant, and effective.
- Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
- Expert-level knowledge of current industry standards for New Product Development and risk management practices.
- Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
What you will need:
- Education: B.Tech/M.Tech in Mechanical Engineering / Computer Science / Biomedical
- 10+ years’ experience in new product development focused on quality engineering related activities.
- Good interpersonal and communication skills
- Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
- Experience on NPD process and various phases of new product development.
- Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.
- Ensure that software, mechanical, electronic, and material/implant engineering follow the same approaches, wherever possible, to ensure seamless cooperation between these diverse disciplines and their associated system responsibilities.
- Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
- Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com