Senior Systems Engineer - Medical Device (San Diego, CA)
This is a great opportunity to contribute to our intravascular imaging and functional measurement consoles team that is responsible for all enabling hardware and software between intravascular ultrasound (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:
Working with a diverse team of highly capable engineers (software and hardware) and multi-functional team-members, the candidate must be able to show technical leadership and be responsible for realization of full systems product release/life cycle management to ensure quality and compliance by translating user and business requirements into product system requirements.
Work with subsystem teams in the decomposition and allocation of derived requirements down to HW/SW element and part requirements. Trade-off of product/system design specifications and interfaces determine feasibility of potential solutions, and leading technical & design reviews.
Ensuring full Product Safety Risk Management in a regulation compliant manner and conduct impact assessments to identify regression testing requirements for design changes.
Develop system interoperability requirements and compatibility statements and perform 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.
Develop system integration plans, technical leadership, and guidance in the integration of HW, SW, and disposables. Managing technological complexity of products in multi-disciplinary setting. Develops products, independently and according to own judgement, using the latest technologies and resources, often realizing systems based on unverified specifications.
Leads R&D teams in solving unique and challenging technical problems
Makes a substantial contribution to the innovation of product and processes.
Ensure the global systems engineering team follows consistent ways of working thru cross-training, knowledge sharing, and guidance documents
Provide guidance and support to the system test team - particularly in the area of standards testing.
You're the right fit if:
You’ve acquired 8+ years of experience in systems engineering in the medical device space.
Your skills include the use of system engineering tools such as use scenarios, context/interface diagrams, functional system modeling, FMEAs, QFD and DfX tools as well as experience with requirements management tools.
You have a Bachelor's degree in engineering. Master’s degree or equivalent experience desired.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
You’re experienced in Medical Development regulations as in FDA 21 CFR part 820, ISO 13485, ISO 14791, The Medical Device Directive, Safety as in EN60601-1 and EMC as in EN60601-1-2 and subordinate regulations.
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:
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Philips Transparency Details:
The pay range for this position in CA is $139,000 to $223,000
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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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.