About this role
<p style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif"><strong>Job Overview</strong></span></p> <p style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Reporting to the Development Manager, the Senior Design Engineer carries out development activities for medical devices, including design, prototyping, technical analyses, and testing. The Senior Design Engineer collaborates closely with cross-functional project teams to ensure that designs meet user needs, quality requirements, and consider manufacturability. The Senior Design Engineer will communicate directly with customers and manufacturing teams and will be required to travel >10% of the time. The Senior Design Engineer will also support regulatory filings for combination products.</span></p> <p style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif"><strong>Main Responsibilities</strong></span></p> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Execute design and development of drug delivery devices following design controls</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Plan testing for characterization, design feasibility, and Design Verification</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Perform technical analyses including statistical analysis and tolerance analysis</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Lead root cause investigations</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Support commercialization and scale-up efforts</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">In a non-supervisory capacity, provide guidance and coaching to team</span></li> </ul> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif"><strong>Skills and Qualification</strong></span></p> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">4-7 years of experience</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">BS Mechanical Engineering/BS Biomedical Engineering</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Proficient at mechanical design (Solidworks preferred)</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Proficient at technical analyses including statistical analysis and tolerance analysis</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Proficient at performing Finite Element Analysis </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Knowledge of manufacturing processes including injection molding</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Knowledge of risk management processes including FMEA</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Knowledge of regulations and standards including: 21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Proficient at oral and written communication</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Demonstrates good judgment as well as cultural, social, and environmental awareness</span></li> </ul> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif"><strong> </strong></span></p> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif"><strong> </strong></span></p> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif"><strong>We Offer</strong></span></p> <p style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <ul style="margin-top:0.0in;margin-bottom:0.0in"> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Competitive compensation package</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Modern working environment with state-of-the-art facilities and technologies</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Challenging assignments in a fast-growing and innovative industry </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Position in a dynamic, international team of highly skilled professionals</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:18.0pt;font-family:arial, helvetica, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Various opportunities for personal and professional development within a global organization</span></li> </ul> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:18.0pt;font-family:arial, helvetica, sans-serif">Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at <a href="mailto:[email protected]">[email protected]</a>.</span></p> <p style="margin:0.0in;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"> </p>