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Senior Safety Engineer
2 months ago
Work Flexibility: Onsite
General Description:
Develops and coordinates testing and evaluation of electronic medical equipment to required safety standards. Oversees development and implementation of manufacturing line tests.
Who We Want
- Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.
Essential Functions:
- Provides technical expertise and management skills in developing safe products and maintaining product safety.
- Supervises and conducts testing and issues electrical safety test reports to assure product safety.
- Determines and authorizes whether products are safe for production and sale.
- Supports quality, manufacturing, technical support and marketing departments on product safety issues in post-production.
- Develops and maintains an in-house electrical safety program (IAW ISO17025) and test lab for certification testing.
- Interprets safety standards and provides technical guidance.
- Ensures compliance with accepted international standards and FDA guidance and optimal achievement of compliance objective.
- Leads or participates in continuous improvement efforts relative to product safety.
- Maintains awareness of current product safety advances and technologies.
- Oversees product safety testing activities performed by outside subcontractors.
- Determines design approaches and parameters and assure commitment to patient safety.
- Reviews vendor capability and supports product development.
- Develop and maintain electrical safety compliance strategy and process
- Review and assure effectiveness of manufacturing safety test process
- Provide technical training to cross function team
- Provide guidance on safety compliance for business acquisition
Preferred Qualifications:
- Bachelor's degree (B.S.) in electrical engineering
- 2+ years related experience or equivalent.
- In depth knowledge of IEC60601-1 and associated standards
- Knowledge of applicable international regulations and standards (MDD, ISO13485 and CMDCAS).
- Commitment to excellence and high standards.
- Excellent written and oral communication skills.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Acute attention to detail and professional concepts.
- Demonstrated ability to plan and organize projects.
- Ability to work independently and as a member of various teams and committees.
- Proficient on Microsoft Word, Outlook, and Excel.
- Proven ability to handle multiple projects and meet deadlines.
- Strong interpersonal skills.
- Professional judgment with the ability to make timely and sound decisions.
- Creative, flexible, and innovative team player.
- Ability to direct and determine cost-effective creative solutions.
- Ability to lead and work on complex projects and provide guidance.
- Ability to work in a fast-paced, dynamic, and deadline-driven work environment.
- Ability to act as primary resource of a cross functional team with regard to product safety
Travel Percentage: 10%
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 contractor's legal duty to furnish information.
