Irvine, CA, 92604, USA
3 days ago
R&D Staff Engineer - Software - Inari
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent. The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 4 or more years experience. Technical Responsibilities: · Independently research, design, develop, modify, and verify components, modules and sub-systems for medical device product development and/or misc. activities. · Translate and/or define user needs to design inputs/specifications and produce complex system level designs with some guidance. · Conduct or design advanced prototyping and testing. · Analyze and correct complex product design issues using independent judgment. Business Responsibilities: · Provide advance solutions by applying in-depth knowledge of customer needs, market and competitive offerings. · Apply detailed knowledge of clinical procedures to author design inputs. · Support voice of customer sessions internally and with clinicians. · Demonstrate developing financial acumen. Med Device Compliance: · Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations. · Lead creation and refinement of engineering documentation, such as the Design History file. · Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System. General Responsibilities: · Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success. · Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology. · Support and execute segments of complex multifunctional teams to advance projects through the design/development/launch process. Technical Skills: · Strong technical ability to develop and optimize designs for mechanical / electro-mechanical assemblies incorporating DFM principles. · Strong technical ability in creating engineering drawings, models, applying GD&T and CAE tools. · Adept at applying knowledge of materials and manufacturing processes to product design. · Ability to communicate moderate complex plans and technical information to team members. - Experience with software in medical devices - Experience at full cycle development from arduino to finished device. - Experience with capital and disposable electronic medical devices - Working knowledge of IEC 60601 · Pre-Clinical and/or Clinical experience. · 510(k) and/or PMA experience. 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.
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