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Urgent! Staff R&D Process Development Engineer Job Opening In Irvine – Now Hiring Stryker
We are seeking a talented Process Development Engineer to support the development and commercialization of our next generation thrombectomy system.
This engineer will play a critical role in developing and validating manufacturing processes that enable reliable production of highly complex interventional devices, with strong collaboration with R&D engineering.
This role is fully onsite role in Irvine, CA with the expectation to be in office 5 days a week.
Check out our product portfolio: Stryker Inari (https://www.inarimedical.com/)
**What you will do:**
+ Develop, optimize, and validate manufacturing processes for next generation thrombectomy devices (capital and disposables)
+ Develop fixtures and equipment for precision assembly and testing of medical devices
+ Utilize strong understanding of process capability analysis (Cp, Cpk, Pp, Ppk), statistical process control (SPC), and other statistical tools (DOE, ANOVA) to ensure process repeatability and scalability
+ Lead IQ/OQ/PQ validations for critical processes such as:
+ Injection Molding
+ Bonding processes (e.g., automated gluing, ultrasonic welding, etc.)
+ In-process inspections and testing (e.g., leak testing)
+ Collaborate with R&D to translate design intent into robust, commercially scalable processes including the use of DFM best practices
+ Support design transfer activities from the R&D environment to a cleanroom environment
+ Support root cause investigations and implement CAPAs for process-related issues
+ Document processes, validations, and risk assessments in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 25539 (vascular implants)
**What you need:**
**Required Qualifications:**
+ Bachelor's degree in Engineering (Mechanical or Biomedical preferred)
+ 4+ years of work experience
**Preferred Qualifications:**
+ Subject Matter Expertise level of understanding pertaining to the design for injection molded parts and molding process development
+ Experience in process development/manufacturing engineering within medical device space specifically for injection molded components
+ Proficiency in fixture/tooling design using SolidWorks CAD
+ Skilled in statistical analysis and software (Minitab, JMP)
+ Familiarity with risk management (DFMEA, PFMEA) and regulatory expectations for Class II/III interventional devices
+ Six Sigma Green/Black Belt certification
$100,700 - $165,100 salary plus bonus eligible + benefits.
Individual pay is based on skills, experience, and other relevant factors.
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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Unlock Your Staff R Potential: Insight & Career Growth Guide
Real-time Staff R Jobs Trends in Irvine, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Staff R in Irvine, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 33879 jobs in United States and 176 jobs in Irvine. This comprehensive analysis highlights market share and opportunities for professionals in Staff R roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Stryker is currently hiring and seeking a Staff R&D Process Development Engineer to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Stryker adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Staff R&D Process Development Engineer Jobs United States varies, but the pay scale is rated "Standard" in Irvine. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Staff R&D Process Development Engineer typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your Staff R&D Process Development Engineer interview at Stryker, research the company, understand the job requirements, and practice common interview questions.
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