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

• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Collaborates with Divisional QA, cross-functional and suppliers' teams to address top quality issues.
• Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified CAPAs and manage to timely root cause investigation, implementation and closure.
• Disposition non-conforming product within MRB, issuing NC's as appropriate.
• Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
• Engage in the development and improvement of the internal manufacturing processes for existing products.
• Performs critical assessment of internal and supplier proposed change management activities.
• Performs PPAP activities for supplier changes
• Participates and may lead in the creation and/or review of new or modified procedures.
• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• Support execution and analysis of manufacturing related complaints and product field actions.
• Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
• Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
• Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
• Support the creation and maintenance of inspection methods and sampling.
• Applies statistical methods of analysis and process control to current operations.
• Engage and interface in internal and external audits providing subject matter expertise
• Support the development and review of process and equipment validation/qualification and MSA processes.
• Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.
• Site Representative for Supplier audits.

• Previous industry experience desired.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Understanding of US and International Medical Device Regulations.
• Familiarity with ISO 13485, GDP, GMP desired.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
• Ability to represent Quality function with project teams.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Strong in critical thinking and ""outside the box"" thinking.
• Highly developed problem-solving skills. Strong analytical skills.
• Demonstrated ability to work independently and as part of cross-functional teams.
• Experience in working in a compliance risk situation.
• Computer literacy.
• Some travel may be required.
• BS in a science, engineering or related discipline.
• MS, CQE, or CRE preferred
• Six Sigma Green or Black belt preferred.
• Minimum of 3 years' experience preferred.