Job Information
Stryker Electrical Safety Engineer- Medical Devices and Systems in San Jose, California
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually, as well other great perks. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)
Summary:
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:
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision while keeping the project team highly inspired and motivated.
What you will do:
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
What you will need:
Bachelor’s degree (B.S.) in electrical engineering
4+ 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).
Preferred Qualification:
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 the primary resource of a cross-functional team with regard to product safety.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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.