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Stryker

Principal Engineer - Design Assurance Sustaining

Stryker, Mahwah, NJ, United States

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Stryker is a Principal Design Assurance – Sustaining to support Joint Replacement in Mahwah, NJ! This role leads risk management and usability activities for Joint Replacement products in line with ISO standards, collaborating with cross-functional teams to address emerging issues and ensure compliance. As part of a global team, the role directs sustaining engineering strategies to maintain product quality, optimize manufacturing, and support continuous improvement initiatives for orthopedic products.

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.

  • 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 in failure modes associated with production and production related processes, (PFMEA).

  • Lead the Risk Management Process through risk Management Principles.

  • Responsible for establishing evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release) through robust pFMEA.

  • Ensure all Risk Management outputs comply with ISO14971.

  • Support Design team to complete CQA/CTQ identification and inputs to dFMEA

  • 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 large-scale 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 company’s quality system and external standards.

  • This role will be on a team whose mission is to efficiently drives rigor in Sustaining activities through creative problem solving and ensures market continuity of safe and effective products.

What you need:

Required:

  • Bachelor’s degree in engineering.

  • 8+ years’ experience in quality, engineering and/or risk management in a highly regulated industry.

  • Experience in quality concepts such as risk management, audits, NC/CAPA, and/or HRAs.

Preferred

  • Experience with ISO 13485, ISO 14971 and/or IEC 62366.

  • Strong interpersonal skills, written communication, and oral communication.

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. Stryker 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. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.