Job Information
Philips Systems Test Engineer - Medical Device (San Diego, CA) in San Diego, California
Systems Test Engineer - Medical Device (San Diego, CA)
You'll contribute to our intravascular imaging and functional measurement consoles. The R&D console team is responsible for all enabling hardware and software between IVUS catheter and pressure guidewires and the output on the console screen. The team’s main goal is to de-risk technical designs in an early stage and demonstrate this with early prototypes and mature them all the way to releasing and maintaining reliable products. The successful candidate can deliver high quality designs within project timelines and considering the medical device compliance.
Your role:
Develop and execute verification test cases for realization of full systems product release/life cycle management to ensure quality and compliance. Work closely with Regulatory stakeholders to ensure compliance to appropriate standards is included in project plans and translate regulatory standards into applicable requirements and test methods
Create Master Regulatory Standards test plans, test protocols, and reports and execute standards testing witnessed by Safety Agencies. Assist with pre-compliance testing in establishing worse-case configurations for standards testing
Work closely with Safety Agencies to schedule, execute, and oversee standards testing
Train Safety Agency test engineers to operate and properly disassemble/reassemble the system under test
Assist with standards gap analysis for updates to IEC Basic Safety, Collateral, or Particular standards for IGTD products to ensure QMS compliance with the latest standard updates. Assist in the development of system integration plans requiring pre-compliance and compliance testing
Provide guidance and support to R&D teams - particularly in the area of standards testing
You're the right fit if:
You have 3+ years of relevant experience as a Test Engineer in the medical device field. Medical device experience is required.
You have experience in the use of test case management tools such as MFALM, RV&S, or Jama as well as experience with project management tools and methodologies.
You have earned a Bachelor’s degree in an Engineering discipline.
Environmental job requirements with or without accommodation for this position.
You are able to travel to Northern California for a few weeks at a time to conduct testing. The travel percentage is around 15% annually.
Familiarity with Medical Development regulations as in FDA 21 CFR part 820, ISO 13485, ISO 14791, EU MDR, and IEC 60601 Basic Safety and Essential Performance including subordinate Collateral and Particular Standards
How we work together:
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office-based role in San Diego, CA.
About Philips:
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business.
Discover our rich and exciting history.
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Learn more about our culture.
Philips Transparency Details:
The pay range for this position in CA is $110,000 to $177,000
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego, CA .
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It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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