Staff Compliance Engineer Hybrid
Staff Compliance Engineer Hybrid
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Job Description
Stryker is hiring a Staff Compliance Engineer to support our Emergency Care division. The work schedule is structured to support flexibility with inoffice presence required Monday through Wednesday and remote work available on Thursday and Friday.
As Staff Compliance Engineer you will evaluate new and revised electromedical devices and accessories to international safety standards. Interfacing with project teams and other departments you will create and maintain evaluation and certification reports as well as Technical Documentation files including reviewing IEC test procedures and reports ensuring compliance with safety standards and requirements conducting inhouse and external testing and managing certifications and requirement checklists.
Responsibilities:
Review and evaluate test data specifications engineering and user documentation physical construction marking and labeling hazard analysis clinical reports Declaration of Conformity EMC protocol and test reports and technical descriptions of essential components and materials
Lead the preparation and revision of Technical Document Files and other certification reports from engineering documentation
Create and maintain overall isolation diagrams
Guide engineering project teams in designing new or revised products to ensure compliance
Manage several projects and collaborate with internal and external department teams
Provide weekly status reports
Implement complex engineering documentation
Develop design and process changes under the direction of senior engineers
Manage the administration of ISO17025 CTF3 Data Acceptance Program between the verification lab and NRTL
What you need
Required
Bachelors degree in biomedical electrical or mechanical engineering or related discipline
Minimum 4 years experience with safety standards product compliance and certifications
Preferred
Familiarity with IEC standards for medical devices such as IEC 606011 and IECISO 17025 ISO 14971 CEMark Technical Documentation Files and safety agencies like UL CSA TUV and BSI
Knowledge of highvoltage circuits and isolation
Experience with test and measurement equipment operation such as dielectric leakage and ground impedance testers and DVMs
Understanding of basic analog circuits and components
$100700.00 $165100.00 USD Annual salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.
Travel Percentage: 0Stryker 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
Employment Type
Full-Time
