Stryker
Staff Engineer, Design Quality - Inari Medical
Stryker, Irvine, California, United States, 92713
Staff Engineer, Design Quality - Inari Medical
Join to apply for the
Staff Engineer, Design Quality - Inari Medical
role at
Stryker Staff Engineer, Design Quality - Inari Medical
3 days ago Be among the first 25 applicants Join to apply for the
Staff Engineer, Design Quality - Inari Medical
role at
Stryker Stryker - Inari Medical is hiring a
Staff Engineer, Design Quality
in
Irvine ,
California ! In this role, you will partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes that support new product development projects. You will also lead risk management activities to ensure the highest level of product and process quality!
What You Will Do:
Develop quality documentation to support new product development and regulatory submissions. Maintain and improve quality systems by identifying and correcting procedural deficiencies. Lead risk management activities and present final risk/benefit justifications to leadership. Drive product and process design activities in cross-functional teams. Define and validate design verification and validation (V&V) test requirements and methods. Present product risks during design reviews and ensure mitigation through development. Support manufacturing process development and product design transfer to internal/external sites. Apply statistical analysis and problem-solving techniques to define acceptance criteria and resolve quality issues. Review and approve inspection plans, routers, and product drawings. Evaluate predicate devices and define critical quality attributes through risk analysis. Contribute to final V&V reports with statistically valid conclusions and graphical summaries. Support early market feedback collection and resolution of initial product concerns.
What You Need:
Required:
Bachelor’s degree in science, engineering or related discipline. 4+ years’ related experience required. Medical device industry experience required. Familiarity with New Product Development (NPD) processes and/or involvement in cross-functional activities supporting product development and commercialization.
Preferred:
MS, CQE, or CRE preferred. Six Sigma Green or Black belts are preferred. Experience with the medical device development lifecycle, including risk management and design/process verification and validation. Proficient in quality tools such as FMEA, GD&T, root cause analysis, and Poka-Yoke, as well as core quality concepts. Proficient in data analysis tools (e.g., Minitab) and interpreting CAD drawings to support design and process evaluations. Proven project management and cross-functional collaboration skills. Excellent communication, problem-solving, and analytical abilities.
$100,700.00 - $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. Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Stryker by 2x Sign in to set job alerts for “Design Engineer” roles.
Costa Mesa, CA $90,000.00-$110,000.00 1 month ago Huntington Beach, CA $80,000.00-$140,000.00 6 months ago Lake Forest, CA $70,000.00-$95,000.00 1 week ago Irvine, CA $85,600.00-$107,000.00 3 days ago Long Beach, CA $108,000.00-$138,000.00 3 days ago Irvine, CA $65,000.00-$162,500.00 1 month ago Long Beach, CA $112,000.00-$143,000.00 2 weeks ago Long Beach, CA $97,000.00-$124,300.00 1 day ago Rancho Santa Margarita, CA $80,000.00-$97,000.00 2 weeks ago Rancho Santa Margarita, CA $80,000.00-$97,000.00 2 weeks ago Orange, CA $80,000.00-$100,000.00 1 week ago Santa Fe Springs, CA $100,000.00-$110,000.00 3 weeks ago Rancho Santa Margarita, CA $80,000.00-$97,000.00 2 weeks ago Brea, CA $84,000.00-$101,000.00 2 weeks ago Irvine, CA $90,000.00-$135,000.00 2 weeks ago Mechanical Engineer II, Cockpit and Trim
Irvine, CA $85,600.00-$107,000.00 12 hours ago Long Beach, CA $80,000.00-$176,400.00 3 days ago Irvine, CA $85,400.00-$94,900.00 3 days ago San Clemente, CA $90,000.00-$105,000.00 4 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Join to apply for the
Staff Engineer, Design Quality - Inari Medical
role at
Stryker Staff Engineer, Design Quality - Inari Medical
3 days ago Be among the first 25 applicants Join to apply for the
Staff Engineer, Design Quality - Inari Medical
role at
Stryker Stryker - Inari Medical is hiring a
Staff Engineer, Design Quality
in
Irvine ,
California ! In this role, you will partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes that support new product development projects. You will also lead risk management activities to ensure the highest level of product and process quality!
What You Will Do:
Develop quality documentation to support new product development and regulatory submissions. Maintain and improve quality systems by identifying and correcting procedural deficiencies. Lead risk management activities and present final risk/benefit justifications to leadership. Drive product and process design activities in cross-functional teams. Define and validate design verification and validation (V&V) test requirements and methods. Present product risks during design reviews and ensure mitigation through development. Support manufacturing process development and product design transfer to internal/external sites. Apply statistical analysis and problem-solving techniques to define acceptance criteria and resolve quality issues. Review and approve inspection plans, routers, and product drawings. Evaluate predicate devices and define critical quality attributes through risk analysis. Contribute to final V&V reports with statistically valid conclusions and graphical summaries. Support early market feedback collection and resolution of initial product concerns.
What You Need:
Required:
Bachelor’s degree in science, engineering or related discipline. 4+ years’ related experience required. Medical device industry experience required. Familiarity with New Product Development (NPD) processes and/or involvement in cross-functional activities supporting product development and commercialization.
Preferred:
MS, CQE, or CRE preferred. Six Sigma Green or Black belts are preferred. Experience with the medical device development lifecycle, including risk management and design/process verification and validation. Proficient in quality tools such as FMEA, GD&T, root cause analysis, and Poka-Yoke, as well as core quality concepts. Proficient in data analysis tools (e.g., Minitab) and interpreting CAD drawings to support design and process evaluations. Proven project management and cross-functional collaboration skills. Excellent communication, problem-solving, and analytical abilities.
$100,700.00 - $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. Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Stryker by 2x Sign in to set job alerts for “Design Engineer” roles.
Costa Mesa, CA $90,000.00-$110,000.00 1 month ago Huntington Beach, CA $80,000.00-$140,000.00 6 months ago Lake Forest, CA $70,000.00-$95,000.00 1 week ago Irvine, CA $85,600.00-$107,000.00 3 days ago Long Beach, CA $108,000.00-$138,000.00 3 days ago Irvine, CA $65,000.00-$162,500.00 1 month ago Long Beach, CA $112,000.00-$143,000.00 2 weeks ago Long Beach, CA $97,000.00-$124,300.00 1 day ago Rancho Santa Margarita, CA $80,000.00-$97,000.00 2 weeks ago Rancho Santa Margarita, CA $80,000.00-$97,000.00 2 weeks ago Orange, CA $80,000.00-$100,000.00 1 week ago Santa Fe Springs, CA $100,000.00-$110,000.00 3 weeks ago Rancho Santa Margarita, CA $80,000.00-$97,000.00 2 weeks ago Brea, CA $84,000.00-$101,000.00 2 weeks ago Irvine, CA $90,000.00-$135,000.00 2 weeks ago Mechanical Engineer II, Cockpit and Trim
Irvine, CA $85,600.00-$107,000.00 12 hours ago Long Beach, CA $80,000.00-$176,400.00 3 days ago Irvine, CA $85,400.00-$94,900.00 3 days ago San Clemente, CA $90,000.00-$105,000.00 4 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr