Senior Software Product Security Engineer Product Security Engineering

This role will establish technical expertise for theProduct security QMS in collaboration withDesign Quality Digital group for Stryker T&E digital product

portfolios (Trauma Foot & Ankle Upper Extremities). The position requiresastrong partnership with product

Development teams to ensure time-to-market customer requirements and technology objectives are met whileensuring compliancewithglobal quality and regulatory requirementsrelated to Product support theprocess owner Product Security in establishing implementing and maintainingGlobal Regulatory and Quality processes and documents supporting our Global QMSandthe divisional QMS.

What will you do:

Primary Responsibilities

• Assist inthefacilitation of internal and third-party audits as needed.

• Should be capable ofinterpreting industry standards and government regulations to drivetheimplementation ofworld-classprocesses that may provide resources and/or help to remove obstacles to team accomplishments.

• Should haveDesign Controls expertise for product development projects from inception through successful Design

• Should have a basic understanding ofproduct security&Risk Management strategies.

• Recommend efficiency and process improvements to product security capabilities and functions.

• Collaborate with product teams to assess security risks. Able toclearly conveydesign control and Product Security-related issues to stakeholders.

• Creating Gap assessment betweendifferent processes and fulfilling the Gaps

• Communicate the security gaps to leadership and propose mitigation solutions.

What You Need:

Knowledge/competence

• 5-8 years. Basic levelExpertise in applying security control frameworks security risk assessments and scoring the severity of securitythreats and vulnerabilities.

• Effectiveverbal and writtencommunicator and consensus-builder

• Demonstrated technical problem-solving SDLC(software development life cycle)understanding.

• Basic Understanding of the vulnerability management life of working in a regulatedmedicalorganization.

Good to have

• ISO 13485 in New Product Development for Software and/or Systems preferred

• FDA Cybersecurity guidance (including FD&C 524B andeSTARupdates)

• Hands on experience in using Agile methodology.

• Understands security risk management processes preferably in the healthcare or medical device industry