Engineer, Design Assurance PSS in Elstree at Stryker Corporation

Date Posted: 10/5/2019

Job Snapshot

Job Description

Main purpose of role Lead design control and risk management processes throughout the patient specific design process. Work cross functionally to drive our company’s mission and strengthen the Stryker Brand. Provide guidance to the design teams to ensure product compliance to the company's quality system and external standards. 

Key tasks 

 

  • Develop quality assurance documentation to support the new product development  process and regulatory submissions. 

  • Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices. 

  • Manage, lead, or assist in resolving nonconformities and CAPA. 

  • Engage in the design, development, manufacturing, and risk management activities for new product development projects. 

  • Lead risk management activities by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls. 

  • Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues. 

  • Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria. 

  • Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support. 

  • Utilise data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.      

Qualifications, skills and desirable experience 

  • Minimum of 0+ years’ experience ideally in a strongly regulated environment such as medical device, military or aerospace industry 

  • Bachelor’s Degree in science, engineering or a related discipline 

  • Experience in risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls is preferred. 

  • Experience in the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria is preferred. 

  • Demonstrated ability to effectively work cross-functionally with other departments to drive safety and performance  

  • Previous experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.      

  • Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.   

Special features 

Stanmore Implants Worldwide Limited operates under strict Quality procedures and where these relate to your role you should aim to achieve the required levels of conformity as necessary.  This will ensure that you are fully aware that any non-compliance or improper performance of your role may occur in a defective device.  You also should need to ensure that you remain up to date with the contents of the Quality manual and how this affects your duties. 

Work From Home: No

Travel Percentage: 10%

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