Why engineering at Stryker?

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

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.
• Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and are driven to complete projects that meet regulations and expectations.
• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

• Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities.
• Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
• Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (at supplier, incoming of materials/components, manufacturing, until product release) through robust pFMEA.
• Ensure all Risk Management outputs comply with ISO14971.
• Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.
• Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.
• Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.
• Provide expertise for NC's & CAPA's related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools.
• Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development.
• Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.
• May support internal and external audits.
• Commit to environmental policy.
• May train others in quality assurance/GMP related topics.
• Lead quality activities during Post Launch Monitoring
• Lead investigation and on-time closure of non-conformances, corrective & preventive actions internally and at suppliers.

• +5 years experience in Quality Assurance or related functional area, preferably in medical device, or other regulated industry.
• B.S. in engineering related discipline or equivalent experience.
• New Product Introduction experience is a plus.
• Strong knowledge in Validation per FDA-QSR and ISO guidelines.
• Bilingual (English and Spanish).
• Knowledge of inspection methods in the design and production of electro-mechanical and/or mechanical equipment.
• Ability to conduct and document technical investigation.
• Familiarity with FDA Guidance on Design Controls and CAPA Methodologies.
• Excellent verbal and written communication skills.

• 12 paid holidays annually
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.