Senior Design & Development Engineer

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    "requisitionDescription": "<div>\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/23.18.17/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/23.18.17/styles/froala_style.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n\n    <div class=\"fr-view\">\n      <div><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;' id=\"isPasted\"><strong><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>Confluent Medical Technologies</span></strong><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>&nbsp;is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. &nbsp;Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><strong><span style='font-size:14px;font-family:\"Open Sans\",sans-serif;color:#222222;'>&nbsp;</span></strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><strong><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>&nbsp;</span></strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><strong><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>Job Description:</span></strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>The Sr. Design &amp; Development Engineer is responsible for leading all phases of the product development process for Confluent&rsquo;s Complex Catheter Center of Excellence in Austin, Texas. The qualified candidate will be expected to work directly with customer and internal engineering, project management, sales, and leadership teams to develop design inputs and project plans, generate design concepts and prototypes, create engineering specifications, identify and work with suppliers, build and evaluate product and production fixturing, specify and order equipment, lead design and process verification and validation, lead pilot production activities and training, produce documentation according to FDA design control requirements in a design history file (DHF), support regulatory submissions, and transfer products to production.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>The Sr. Design &amp; Development Engineer may function as an individual contributor or lead a small cross-functional team of engineering, operations, and quality staff members to work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and regulations.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><strong><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>Job Roles and Responsibilities:</span></strong><br><br></p><ul style=\"list-style-type: undefined;margin-left:0in;\"><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Understands and adheres to principles of FDA Design Control (FDA 21 CFR 820.30) and Quality Management Systems (ISO 13485) for product development</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Uses project management tools to manage individual and team-based medical device development projects</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Works with project managers to plan and schedule activities necessary to meet project timelines</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Develops device input requirements and engineering specifications</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Writes and executes validation (IQ/OQ/PQ) protocols and reports with limited supervision</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Develops test methods and executes test method validation</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Collects data and conducts statistical analysis using statistical evaluation tools, i.e. Minitab</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Identifies and manages mitigation of product, process, and project risk according to principles of ISO 14971</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Creates,&nbsp;edits, and reviews all engineering documentation related to assigned projects, such as technical reports, work instructions, validation and verification protocols and reports, memos, risk management plans, device history records, etc.</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Interacts with customers, suppliers, and internal resources</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Advises, trains, and mentors junior engineers</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Synthesizes critical information and complex data and clearly communicates engineering implications to project managers and project stakeholders</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Provides engineering services in a phased development approach to develop &amp; launch medical devices and the fixturing and processes required to manufacture those products</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Provides guidance and technical expertise to find the root cause and fix product and process problems</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Develops product and process designs and accompanying drawings and specifications</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Works cooperatively with quality, manufacturing, regulatory, clinical, sales, and marketing personnel to ensure project success</span></li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><strong><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>Requirements:</span></strong></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>&nbsp; &nbsp;&nbsp;</span></p><ul style=\"list-style-type: undefined;margin-left:0in;\"><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>BS in Engineering or related field (Mechanical, Biomechanical, Industrial)</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>8+ years of related work experience in the medical device or a related field preferred</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Proficiency in computer programs for 3D modeling, i.e. SolidWorks</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>The ability to perform statistical analysis using k-factors, Cpk/Ppk, and DOEs along with root cause analysis (Required)</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Knowledge of geometric dimensioning and tolerancing (GD&amp;T) preferred</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>The ability to lead a team toward operational objectives with the aptitude to contribute to strategic goal-setting for a department/business unit</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Ability to function with no supervision</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach, including creation of risk assessments &amp; failure modes and effects analysis (RA/FMEA)</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Subject matter expertise in a directly applicable field (e.g. medical device development, mechanical assembly, catheter systems, injection molding, extrusions, electro-mechanical, etc.</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Design for manufacturability (DFM) preferred</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Experience with medical process validation, including supporting validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&amp;R, and measurement systems analysis (MSA)&nbsp;</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Experience and understanding of the design for plastics injection-mold fabrication processes preferred</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Ability to perform statistical analysis to ensure quality output of components &amp; assemblies preferred.</span></li><li><span style='font-family:\"Arial\",sans-serif;font-size:12.0pt;color:#222222;'>Working knowledge of Google suite of products preferred</span></li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;line-height:normal;font-size:15px;font-family:\"Calibri\",sans-serif;background:white;'><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:#222222;'>&nbsp;</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'><strong><span style='font-size:16px;line-height:107%;font-family:\"Arial\",sans-serif;color:#414141;'>C</span></strong><span style='font-size:16px;line-height:107%;font-family:\"Arial\",sans-serif;'>onfluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:107%;font-size:15px;font-family:\"Calibri\",sans-serif;'><em><span style='font-size:16px;line-height:107%;font-family:\"Arial\",sans-serif;color:black;'>&nbsp;</span></em></p><p style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 15px; font-family: Calibri, sans-serif; background: white; text-align: center;\"><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:black;background:white;'>We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.&nbsp;</span></p><p style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 15px; font-family: Calibri, sans-serif; background: white; text-align: center;\"><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:black;background:white;'>Confluent Medical Technologies is an equal opportunity employer.&nbsp;</span></p><p style=\"margin: 0in 0in 8pt; line-height: normal; font-size: 15px; font-family: Calibri, sans-serif; background: white; text-align: center;\"><span style='font-size:16px;font-family:\"Arial\",sans-serif;color:black;background:white;'>Only qualified candidates will be contacted.&nbsp;</span></p></div>\n    </div>\n  </div>\n",
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