Staff Engineer, Design Validation (HYBRID)

Weston, WI - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

What You Will Do

Lead design validation activities including preparing stimulated use environments participant recruitment defining sample sizes and acceptance criteria for successful execution of clinical customer-centric labs.
Collaborate with cross-functional teams to develop high quality user needs and product requirements based on Regulatory strategy Marketing inputs and applicable standards.
Participate in various Usability and Human Factors activities to refine User Needs and validate all aspects of device design packaging labeling and training.
Determine appropriate Design validation methods that are statistically significant objective and clinically relevant for testing the Intended Use of the product and User Needs.
Develop technical expertise in complex 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 and risk.
Use strong Systems Engineering principles and FDA Design Controls knowledge to drive best practices in User Needs Requirements and V&V activities.
Ensure all design validation activities are conducted in accordance with relevant regulations and standards and industrys best practices.

What You Need (Required Qualifications)

Bachelors degree in Biomedical Engineering Electronic/Electrical Engineering Human Factors Engineering or Lifesciences discipline
4 years of industry experience validating complex hardware/ software or systems or performing Human Factors/Usability evaluations.
Experience within the medical device industry

Preferred Qualifications:

Strong understanding of relevant medical device regulations and standards such as FDA Guidance documents IEC -1-6 HE75
Experience in Customer-centric Design User Needs Research Accuracy Testing and working through different stages of med tech development.
Background in Navigation Robotic and complex software-based medical technologies.
Strong collaborative and leadership skills with the ability to work effectively with cross-functional teams.

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 DoLead design validation activities including preparing stimulated use environments participant recruitment defining sample sizes and acceptance criteria for successful execution of clinical customer-centric labs.Collaborate with cross-functional teams to develo...

Work Flexibility: Hybrid

What You Will Do

Lead design validation activities including preparing stimulated use environments participant recruitment defining sample sizes and acceptance criteria for successful execution of clinical customer-centric labs.
Collaborate with cross-functional teams to develop high quality user needs and product requirements based on Regulatory strategy Marketing inputs and applicable standards.
Participate in various Usability and Human Factors activities to refine User Needs and validate all aspects of device design packaging labeling and training.
Determine appropriate Design validation methods that are statistically significant objective and clinically relevant for testing the Intended Use of the product and User Needs.
Develop technical expertise in complex 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 and risk.
Use strong Systems Engineering principles and FDA Design Controls knowledge to drive best practices in User Needs Requirements and V&V activities.
Ensure all design validation activities are conducted in accordance with relevant regulations and standards and industrys best practices.

What You Need (Required Qualifications)

Bachelors degree in Biomedical Engineering Electronic/Electrical Engineering Human Factors Engineering or Lifesciences discipline
4 years of industry experience validating complex hardware/ software or systems or performing Human Factors/Usability evaluations.
Experience within the medical device industry

Preferred Qualifications:

Strong understanding of relevant medical device regulations and standards such as FDA Guidance documents IEC -1-6 HE75
Experience in Customer-centric Design User Needs Research Accuracy Testing and working through different stages of med tech development.
Background in Navigation Robotic and complex software-based medical technologies.
Strong collaborative and leadership skills with the ability to work effectively with cross-functional teams.

Travel Percentage: 20%

Required Experience:

Staff IC

Key Skills

Python
SOC
Debugging
C/C++
FDA Regulations
Minitab
Technical Writing
GAMP
OS Kernels
Perl
cGMP
Manufacturing

Apply Now

About Company

Stryker

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 ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click