Senior Manager, Software Quality Assurance - Robotics - Davie, FL - Stryker Corporation

Date de publication : 9/10/2019

Résumé de l'offre

Description de l'offre

Who we want

Stryker’s Mako Robotics Quality team based in Davie, FL is actively seeking a collaborative, insightful and adaptable Senior Manager, Software Quality Assurance – Robotics . If you can enable innovation through quality driven processes and advocate for sustained success through compliant yet progressive SDLC, then this role is for you! We are seeking a driver of talent and a process leader who can partner with our R&D and Regulatory team to ensure the Stryker quality standard.

What you will do  

As a Senior Manager, Software Quality Assurance – Robotics you will be a key contributor dealing with cutting edge technology in the medical device industry.  This is a highly innovative and global role that will develop a team and partner across the organization. 

  • Oversee Software  Quality Assurance activities to support design and development of medical devices as follows.
  • Oversee software risk management activities for products.
  • Develop insights related to customer needs, product risks, and product performance requirements.
  • Partner with R&D, Marketing, Regulatory, and AO to optimize Software Development Life Cycle process for maximum effectiveness, efficiency, compliance, and transparency.    
  • Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
  • Ensure development, implementation, and maintenance of departmental SOPs.
  • Prepare and manage budget for the Software Quality Assurance department.
  • Ensure divisional achievement of quality, regulatory, and compliance targets. 
  • Ensure effective implementation of all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971, EN ISO 62304 throughout the design and development process.

What you need

  • Bachelor’s degree in Science or Engineering - Computer Science preferred
  • Master’s degree preferred
  • 12 + years of experience within regulated industry – Medical Device preferred
  • 8+ years of experience with software and or network development highly preferred
  • Experience with software development life cycle (SDLC), preferably compliant with IEC 62304, preferably in a quality role.
  • Experience with software risk analysis highly preferred.
  • Experience with software development methodologies, e.g., Agile, Waterfall, Scrum highly preferred
  • Experience with both embedded software and software for graphical user interfaces highly preferred

Work From Home: No

Travel Percentage: Up to 25%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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