- Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
- Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
- 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.
- Guide engineering project teams in designing new or revised products that will be compliant
- Participate in all product design review phases to identify and minimize compliance related risks.
- Create/Manage a Product Compliance Matrix before starting regulatory approval by working closely with the HW, Antenna, SW, Program and Product Management teams on regulatory requirements and project schedules.
- Work with engineering team to identify requirements in terms of bands, Carrier Aggregation (CA) and EN-DC combinations and other product features for 4G LTE and 5G-NR
- Organize and coordinate RF/EMC pre-compliance and product safety testing for devices and accessories.
- Organize and coordinate general device and accessory testing before submitting devices to regulatory labs.
- Work with internal teams to plan and manage certification activities with external third-party regulatory labs.
- Review the final reports submitted by regulatory labs and Certification Bodies (NB, TCB) and work with them for submitting the final reports for approvals.
- Write Declaration of Conformity letters for products targeting global markets
- Work with labeling team to address labeling requirements for products, packaging, and user documentation.
- Help to ensure that product information files and/or submissions are accurate and verifiable against source documents to confirm compliance and traceability.
- Manage multiple projects and work on internal and external department teams.
- Provide weekly status reports.
- Implement engineering documentation of high complexity.
- Bachelor's degree in biomedical engineering or related discipline required
- 5+ years of work experience within the medical device industry required
- Experience with Regulatory and conformance certification requirements for major regulatory authorities including FCC (US), ISED (Canada), CE (EU), MIC (Japan) and other international regulatory authorities preferred
- Experience working with and managing third-party certification labs preferred
- Strong interpersonal and communication skills; ability to translate complex rules, standards and regulations with an in-depth understanding and high level of accuracy.
- Strong knowledge of regulatory certification and device submission processes
- Time management and organizational skills required; ability to manage multiple projects simultaneously with a great deal of attention to details.
- Flexible team player with the desire to learn new processes, products, and technologies.
- 12 paid holidays annually
- 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.
Staff Radio Compliance Engineer - Redmond, United States - Stryker
Description
Why RA/QA at Stryker?
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at one of the World's Best Workplaces, apply now
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team:
We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine Learn more about our award-winning organization by visiting
Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at
We are currently seeking a Staff Radio Compliance Engineer , to join our Medical Division. This is an individual contributor opportunity, Hybrid in Redmond, Washington .
Who We Want
What you will do
As the Staff Radio Compliance Engineer, you will function in the identification of new and revised international safety standards and regulation for radio equipment in electro-medical devices and accessories. Responsible for working with cross-functional partners on design requirements, the creation and maintenance of radio compliance plans, evaluation/certification reports and declarations of conformity. Also responsible for obtaining FCC (US), ISED (Canada), CE (EU), MIC (Japan) and other international regulatory compliance approvals.
What you need
$98,300 - $161,100 USD salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
About Stryker
Our benefits:
For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits (https://cdn-)
About 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. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at (http:)
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page )
Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, 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.