We are currently seeking a PrincipalDesign Validation Engineer to join our team in Weston FL. This is a senior technical leader responsible for defining and scaling design validation strategy for complex medical devices and this role you will develop new design validation strategies for advanced navigation and surgical robotics programs shape validation methodology across product portfolios and drive cross-functional alignment on user needs requirements traceability design controls and evidence generation needed to support safe effective and compliant product development and successful regulatory submissions. Your work will directly contribute to bringing new products to market that meet clinical needs and uphold the highest standards of quality and performance.
As a Principal Design Validation Engineer you will apply core engineering principles across multiple disciplines to drive design validation activities. You will play a critical role in translating high level VOCs to User Needs developing clinically relevant validation strategies executing validation studies in different simulated use environments ensuring that our products meet technical specifications and latest regulatory requirements. This role offers the opportunity to work on a global team in a dynamic collaborative environment that values innovation precision and a commitment to improving patient outcomes.
Technical Responsibilities:
Lead enterprise-level or multi-program design validation strategy including validation planning execution frameworks statistical rationale acceptance criteria and final design validation conclusions for complex hardware software and systems-based medical devices.
Drive development of robust user needs intended use validation approaches and end-to-end validation frameworks in partnership with Systems Engineering R&D Clinical Regulatory Quality Marketing and Human Factors teams.
Define and oversee advanced design validation methods that are objective clinically relevant risk-based and statistically justified for intended users use environments and surgical workflows.
Provide technical leadership for complex validation efforts involving cutting-edge navigation and robotics-assisted orthopedic systems and apply in-depth knowledge of the operating room environment to inform test method development data interpretation and evaluate product performance.
Provide leadership in setting direction for meeting US AND EUs latest regulatory requirements for quantitative clinical accuracy design validation methods.
Lead the integration of diverse medical subsystems into cohesive customer-ready solutions optimizing interoperability workflow efficiency and overall system performance.
Mentor and influence in creation and correction of complex design validation test methodologies for product design issues.
Possesses an in-depth knowledge of the industry and competitive landscape. Partner in generating innovative insights and developing frameworks to prevent field issues by discovering business needs and validating them before product launch.
What You Will Need:
Required Qualifications:
Bachelor of Science in Mechanical Engineering Biomedical Engineering Electrical Engineering Human Factor Engineering or related Lifesciences discipline.
Minimum 8 years of work experience validating complex hardware/ software or systems or performing Human Factors/Usability evaluations
Preferred Qualifications:
Experience in Customer-centric Design User Needs Research Accuracy Testing and working through different stages of med tech development.
Strong understanding of Systems Engineering principles relevant medical device regulations and standards such as FDA Guidance documents IEC -1-6 ANSI HE75.
Demonstrates mastery in technical writing for complex engineering documentation including reports protocols procedures and design specifications. Capable of establishing documentation standards mentoring others in technical writing and ensuring clarity and regulatory compliance across all deliverables.
Apply deep understanding of statistical methodologies to guide design validation and integration. Partner with cross-functional teams to interpret data and ensure adherence to design controls and regulatory expectations throughout new product development.
Exhibit proactive leadership champion continuous improvement foster innovation and mentor others in analytical and systematic thinking to achieve high-quality compliant engineering outcomes.
$135600 - $225900 USD Annual
Travel Percentage: 20%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 contractors legal duty to furnish information.
Required Experience:
Staff IC
Work Flexibility: HybridWhat You Will Do:We are currently seeking a Principal Design Validation Engineer to join our team in Weston FL. This is a senior technical leader responsible for defining and scaling design validation strategy for complex medical devices and this role you will develop new de...
Work Flexibility: Hybrid
What You Will Do:
We are currently seeking a PrincipalDesign Validation Engineer to join our team in Weston FL. This is a senior technical leader responsible for defining and scaling design validation strategy for complex medical devices and this role you will develop new design validation strategies for advanced navigation and surgical robotics programs shape validation methodology across product portfolios and drive cross-functional alignment on user needs requirements traceability design controls and evidence generation needed to support safe effective and compliant product development and successful regulatory submissions. Your work will directly contribute to bringing new products to market that meet clinical needs and uphold the highest standards of quality and performance.
As a Principal Design Validation Engineer you will apply core engineering principles across multiple disciplines to drive design validation activities. You will play a critical role in translating high level VOCs to User Needs developing clinically relevant validation strategies executing validation studies in different simulated use environments ensuring that our products meet technical specifications and latest regulatory requirements. This role offers the opportunity to work on a global team in a dynamic collaborative environment that values innovation precision and a commitment to improving patient outcomes.
Technical Responsibilities:
Lead enterprise-level or multi-program design validation strategy including validation planning execution frameworks statistical rationale acceptance criteria and final design validation conclusions for complex hardware software and systems-based medical devices.
Drive development of robust user needs intended use validation approaches and end-to-end validation frameworks in partnership with Systems Engineering R&D Clinical Regulatory Quality Marketing and Human Factors teams.
Define and oversee advanced design validation methods that are objective clinically relevant risk-based and statistically justified for intended users use environments and surgical workflows.
Provide technical leadership for complex validation efforts involving cutting-edge navigation and robotics-assisted orthopedic systems and apply in-depth knowledge of the operating room environment to inform test method development data interpretation and evaluate product performance.
Provide leadership in setting direction for meeting US AND EUs latest regulatory requirements for quantitative clinical accuracy design validation methods.
Lead the integration of diverse medical subsystems into cohesive customer-ready solutions optimizing interoperability workflow efficiency and overall system performance.
Mentor and influence in creation and correction of complex design validation test methodologies for product design issues.
Possesses an in-depth knowledge of the industry and competitive landscape. Partner in generating innovative insights and developing frameworks to prevent field issues by discovering business needs and validating them before product launch.
What You Will Need:
Required Qualifications:
Bachelor of Science in Mechanical Engineering Biomedical Engineering Electrical Engineering Human Factor Engineering or related Lifesciences discipline.
Minimum 8 years of work experience validating complex hardware/ software or systems or performing Human Factors/Usability evaluations
Preferred Qualifications:
Experience in Customer-centric Design User Needs Research Accuracy Testing and working through different stages of med tech development.
Strong understanding of Systems Engineering principles relevant medical device regulations and standards such as FDA Guidance documents IEC -1-6 ANSI HE75.
Demonstrates mastery in technical writing for complex engineering documentation including reports protocols procedures and design specifications. Capable of establishing documentation standards mentoring others in technical writing and ensuring clarity and regulatory compliance across all deliverables.
Apply deep understanding of statistical methodologies to guide design validation and integration. Partner with cross-functional teams to interpret data and ensure adherence to design controls and regulatory expectations throughout new product development.
Exhibit proactive leadership champion continuous improvement foster innovation and mentor others in analytical and systematic thinking to achieve high-quality compliant engineering outcomes.
$135600 - $225900 USD Annual
Travel Percentage: 20%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 contractors legal duty to furnish information.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid
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