Staff Engineer, Design Validation

Weston, WI - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

What You Will Do:

Collaborate with cross-functional teams to develop the best in-class user needs that drive objective validation studies.
Lead various design validation activities including preparing stimulated use environments defining sample size and acceptance criteria managing participant recruitment for Digital Robotics and Enabling Tech products.
Develop and validate all clinically relevant use cases for navigated and robotic orthopedic procedures by engaging with KOLs observing clinical procedures etc.
Apply in-depth knowledge of the operating room environment and complex medical technology to perform clinically relevant design validation testing.
Participate in various user-centric development activities and confirm user needs are met effectively in all aspects of device design packaging labeling and training.
Use strong Systems Engineering Principles to drive best practices in User Needs Requirements and V&V activities.
Collaborate with various cross-functional teams such as Medical Education and Marketing to mimic field-training in support of successful medical device launch.
Ensure all design validation activities are conducted in accordance with relevant regulations and standards and industrys best practices.

What You Will 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
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 User Needs Research Design validation and med tech product development.
Excellent problem-solving analytical and communication skills.
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 Do:Collaborate with cross-functional teams to develop the best in-class user needs that drive objective validation studies. Lead various design validation activities including preparing stimulated use environments defining sample size and acceptance criteria man...

Work Flexibility: Hybrid

What You Will Do:

Collaborate with cross-functional teams to develop the best in-class user needs that drive objective validation studies.
Lead various design validation activities including preparing stimulated use environments defining sample size and acceptance criteria managing participant recruitment for Digital Robotics and Enabling Tech products.
Develop and validate all clinically relevant use cases for navigated and robotic orthopedic procedures by engaging with KOLs observing clinical procedures etc.
Apply in-depth knowledge of the operating room environment and complex medical technology to perform clinically relevant design validation testing.
Participate in various user-centric development activities and confirm user needs are met effectively in all aspects of device design packaging labeling and training.
Use strong Systems Engineering Principles to drive best practices in User Needs Requirements and V&V activities.
Collaborate with various cross-functional teams such as Medical Education and Marketing to mimic field-training in support of successful medical device launch.
Ensure all design validation activities are conducted in accordance with relevant regulations and standards and industrys best practices.

What You Will 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
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 User Needs Research Design validation and med tech product development.
Excellent problem-solving analytical and communication skills.
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

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