Principal Engineer
Principal Engineer
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Job Description
What you will do
This role will lead and evaluate risk management and usability activities and systems for Joint Replacement products currently in the field in accordance with ISO 13485 ISO 14971 and IEC 62366.And lead the Risk Management Process through risk Management Principles.
This role will provide direction and partner with technical and managerial leaders on emerging issues (NC/CAPA Regulatory Requests) Joint Replacement Lifecycle Management (Product Transfers Supplier Initiated Change Requests) and Base Business Requests (Risk Management Periodic Review EUMDR Compliance Health Risk Assessments).
Proficient in risk management practices and tools having high expertise infailure modes associated with production and production related processes(PFMEA).
Responsible for establishing evaluation of process risks risk mitigation and ensuresappropriate production and process controls are identified qualified andimplemented throughout the product manufacturing lifecycle (from incomingof materials/components manufacturing until product release) throughrobust pFMEA.
Ensure all Risk Management outputs comply with ISO14971.Support Design team to complete CQA/CTQ identification and inputs todFMEA
This role will establish and influence guidance documents and internal trainings to cross functional teams on areas of experience for risk management and usability as well as present externally in audits on our risk management files.
This role will seek out and drive collaboration with cross functional partners from various groups including Product Development Regulatory and Clinical to solve technical problems regarding our existing orthopedic products
This role will represent Design Assurance and direct risk management strategy in global initiatives to improve the cost and manufacturing on Stryker devices.
This role will identify evaluate and lead continuous improvements projects within the Design Assurance team to implement new efficiencies into daily deliverables and largescale tasks
This role will be a part of a global team that drives engineering activities in the maintenance of orthopedic products to ensure the highest level of product quality and ensure compliance to the companys quality system and external standards.
This role will be on a team whose mission is to efficiently drivesrigorin Sustainingactivities through creativeproblem solvingand ensures market continuity ofsafeandeffectiveproducts.
What we need
Required:
Minimum of 8 years experience in quality engineering and/or risk management in a highly regulated industry.
Bachelors Degree in engineering
Experience with ISO 13485 ISO 14971 and/or IEC 62366.
Experience in quality concepts (risk management audits NC/CAPA HRAs).
Strong interpersonal skills written communication and oral communication.
Preferred:
- Medical device industry experience
- Clinical knowledge of Orthopadics industry.
- Strong analytical skills; Effective interpersonal skills and Strong communications skills.
- Exposure in working with cross functional team and influencing without authority.
Required Experience:
Staff IC
Employment Type
Full-Time
