Jobs via Dice
Staff R&D Engineer - Sustaining & Model Development
Jobs via Dice, Irvine, California, United States, 92713
Overview
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Staff R&D Engineer - Sustaining & Model Development
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Jobs via Dice Work Flexibility: Onsite At Stryker's Inari Medical, we are transforming the lives of patients suffering from venous and other vascular diseases through purpose-driven innovation. As a fast-growing medical device company, we develop breakthrough technologies that treat life-threatening conditions with speed, safety, and precision. Join us in shaping the future of vascular health. The Staff R&D Engineer supports and leads project teams in the development of medical device products - this includes writing or verifying specifications, developing testing and product processes, and designing fixtures to ensure the concepts and/or prototypes meet requirements. Learn more about the Division Here: Inari Medical
What You Will Do
Independently research, design, develop, modify, and verify mechanical components for medical devices while working cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success. Conduct or design advanced prototyping and testing. Create benchtop models to simulate clinically relevant and challenging use conditions. Support Voice of Customer sessions internally and with clinicians. Analyze and correct complex product design issues using independent judgment. Ensure traceability and compliance with requirements, including ISO 13485, EUMDR, and other international regulations. Support and execute segments of complex multifunctional teams to advance post-launch design changes at the material, component, and supplier level. 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.
What You Will Need
Required Qualifications:
Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or related discipline 4+ years of work experience in a regulated industry Proficient in 3D CAD modeling (Solidworks Preferred) Experience with design control Preferred Qualifications:
Experience in creating engineering drawings, models, applying GD&T, and CAE tools to optimize the design Adept at applying knowledge of materials and manufacturing processes to product design Pre-clinical and/or clinical experience 510(k) and/or PMA experience
Salary: $100k - $165k salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 20%
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.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor\'s legal duty to furnish information.)
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Join to apply for the
Staff R&D Engineer - Sustaining & Model Development
role at
Jobs via Dice Work Flexibility: Onsite At Stryker's Inari Medical, we are transforming the lives of patients suffering from venous and other vascular diseases through purpose-driven innovation. As a fast-growing medical device company, we develop breakthrough technologies that treat life-threatening conditions with speed, safety, and precision. Join us in shaping the future of vascular health. The Staff R&D Engineer supports and leads project teams in the development of medical device products - this includes writing or verifying specifications, developing testing and product processes, and designing fixtures to ensure the concepts and/or prototypes meet requirements. Learn more about the Division Here: Inari Medical
What You Will Do
Independently research, design, develop, modify, and verify mechanical components for medical devices while working cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success. Conduct or design advanced prototyping and testing. Create benchtop models to simulate clinically relevant and challenging use conditions. Support Voice of Customer sessions internally and with clinicians. Analyze and correct complex product design issues using independent judgment. Ensure traceability and compliance with requirements, including ISO 13485, EUMDR, and other international regulations. Support and execute segments of complex multifunctional teams to advance post-launch design changes at the material, component, and supplier level. 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.
What You Will Need
Required Qualifications:
Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or related discipline 4+ years of work experience in a regulated industry Proficient in 3D CAD modeling (Solidworks Preferred) Experience with design control Preferred Qualifications:
Experience in creating engineering drawings, models, applying GD&T, and CAE tools to optimize the design Adept at applying knowledge of materials and manufacturing processes to product design Pre-clinical and/or clinical experience 510(k) and/or PMA experience
Salary: $100k - $165k salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 20%
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.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor\'s legal duty to furnish information.)
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