Sr Quality Engineer, Capital Equipment

<span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><b><span style="font-size:12pt;"><span style="line-height:115%;"><span style="font-family:Roboto;">Job Title: Sr Quality Engineer</span></span></span></b></span></span></span><br><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><b><span style="font-family:Roboto;">Location</span></b><i><span style="font-family:Roboto;">: This position is based in our Campbell, California offices. This position is <u>full time.</u></span></i></span></span></span><br><br><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><b><span style="font-family:Roboto;"><span style="color:#ed7d31;">Why Imperative Care?</span></span></b></span></span></span><br><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated.&#160;As part of our team, you&#8217;d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.</span></span></span></span><br><br><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><b><span style="font-family:Roboto;"><span style="color:#ed7d31;">What You&#8217;ll Do</span></span></b></span></span></span><br><span style="font-size:11pt;"><span><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;"><span style="color:#000000;">As a senior professional in this field, this position will use solid knowledge and experience and contribute to the development, manufacture, and distribution of Imperative Care&#8217;s medical device products by applying Quality Engineering principles to all applicable processes and procedures in accordance with the Company&#8217;s Quality Policy and Quality Objectives.</span></span>&#160; </span></span></span></span><ul style="margin-top:8px;margin-bottom:8px;"><li style="margin-right:49px;margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Provide quality support for medical device R&amp;D and manufacturing activities throughout all phases of the product development process (e.g. requirement development, specification development, verification and validation testing, design transfer, risk assessment, usability, design change control).</span></span></span></span></li><li style="margin-right:49px;margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Participate and contribute to the development of product design history file and ensure compliance to internal processes and external standards and regulations. </span></span></span></span></li><li style="margin-right:49px;margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Collaborates with team members to define requirements, specifications, testing, and component/product acceptance activities.</span></span></span></span></li><li style="margin-right:49px;margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Participate in risk management process ensuring that all the risks were properly identified/assessed and update risk management files accordingly.</span></span></span></span></li><li style="margin-right:49px;margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Direct interaction with suppliers to qualify and maintain approved supplier status, as well as oversee supplier process validation activities.&#160; May be required to evaluate supplier notification of change and recommend necessary actions to maintain compliance</span></span></span></span></li></ul><br><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><b><span style="font-family:Roboto;"><span style="color:#ed7d31;">What You&#8217;ll Bring</span></span></b></span></span></span><ul style="margin-top:8px;margin-bottom:8px;"><li style="margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Bachelor&#8217;s degree in related field (science, industrial operations, mechanical, biomedical, or electrical engineering) and a minimum of 5 years&#8217; work experience in the medical device, or related regulated industry experience; or equivalent combination of education and work experience</span></span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Experience working with electro-mechanical medical device, robotics, or medical software is highly desired.</span></span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC 60601-1, IEC 62304 medical device software, cybersecurity, and related regulations</span></span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)</span></span></span></span></li></ul><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><b><span style="font-family:Roboto;"><span style="color:#ed8b00;">Employee Benefits</span></span></b> <span style="font-family:Roboto;">include </span><span style="font-family:Roboto;">a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.</span></span></span></span><br><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><b><span style="font-family:Roboto;">Join Us! </span></b><a href="https://imperativecare.com/careers/" style="color:#0000FF;text-decoration:underline;"><b><span style="font-family:Roboto;"><span style="color:#ed8b00;">Apply Today</span></span></b></a><span class="MsoHyperlink" style="color:#0000FF;"><span style="text-decoration:underline;"><b><span style="font-family:Roboto;"><span style="color:#ed8b00;">.</span></span></b></span></span></span></span></span><br><br><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;"><span style="font-family:Roboto;">Salary Range: $120,000 &#8211; 150,000/annually</span></span></span></span><br><span style="font-size:11pt;"><span style="line-height:115%;"><span style="font-family:Calibri, sans-serif;"><span style="background:#FFFFFF;"><span style="font-family:Roboto;"><span style="color:#202124;">Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.&#160;</span></span></span></span></span></span><br>&#160;<p>The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.</p> <p>Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.</p>