Senior Compliance Engineer – Digital Health
Job Location:
Portage, WI - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
The Senior Compliance Engineer will provide dedicated compliance engineering support for Stryker Medicals growing Smart Care portfolio. Software as/in a Medical Device (SaMD SiMD) will comprise the portfolio core along with supporting hardware sensors and customer applications. Partner with diverse teams to drive best in market digital health solutions supporting the caregiver patient and families. Grow and adapt the technology & test roadmap to align with business ambition and future technology integration. Support digital and connected ecosystems through standards interpretation and test method mastery. Ensure state of the art interpretation of global compliance standards for medical and non-medical markets to enable globalization portfolio growth.
This is a highly specialized individual contributor role that requires deep technical expertise and professional judgment. The Staff Compliance Engineer - Digital serves as a technical thought leader providing guidance influence and direction across product development certification strategy and organizational best practices.
Check out the products youll support here: Smart Care Stryker
This role is hybrid expecting a minimum of 3 days a week in the Portage MI office typically Monday through Wednesday.
What You Will Do
Lead product compliance strategy for new product development and sustaining engineering activities across the Smart Care portfolio.
Translate global regulatory and compliance requirements into design inputs verification plans and market access strategies.
Drive compliance activities throughout the product lifecycle from concept development through verification validation and commercialization.
Assess compliance risks predicate product considerations and emerging requirements to support informed design and business decisions.
Partner with cross-functional teams to integrate compliance requirements into system architecture product design and technology roadmaps.
Define compliance test strategies methods operating environments and worst-case conditions to ensure robust product evaluations.
Manage external testing laboratories certification bodies and third-party partners to support global certifications and regulatory submissions.
Serve as a technical compliance subject matter expert providing guidance during design reviews risk assessments and development activities.
Influence organizational compliance practices by supporting procedure development technical reviews innovation opportunities and cross-business initiatives.
Collaborate with stakeholders and business units to ensure compliance strategies align with user needs product classifications and market requirements.
What You Need (Required Qualifications)
Bachelors degree in Computer Science Software/Electrical Engineering or related discipline.
4 years of compliance engineering experience .
Preferred Qualifications
Masters degree in Computer Science Software/Electrical Engineering or related discipline.
Experience with product safety regulatory certification for major standards bodies and frameworks (IEC 60601-1 IECFCC Requirements IEC 62368-1 and others)
Experience with medical device product development lifecycle including design controls and risk management.
Experience working with and managing third-party certification laboratories (e.g. UL TÜV CSA Intertek).
Experience with device regulatory certification involving safety EMC and/or wireless standards.
Able to balance business and technical challenges to achieve financial outcomes.
Knowledge of telecom/non-medical device standards.
Familiarity with different software development life cycles.
Basic knowledge of regulatory certification and device submission processes.
Demonstrated ability to work independently and effectively in a matrixed organization.
Demonstrated ability to effectively work cross-functionally with other departments including Research & Development Regulatory Affairs and Marketing.
Strong written verbal and interpersonal communication skills with the ability to influence without authority.
$77700 - $129500 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:
Senior IC
About Company
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
