Senior Product Development Engineer

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      "role": "<meta><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">About the role</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">The Senior Product Development Engineer will support the design and development of Class II and Class III medical devices and their associated delivery systems. This role requires strong analytical and technical skills, adherence to Quality System Regulations, and the ability to operate independently in a fast‑paced, hands‑on environment. This is a full‑time, on‑site position.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">What you'll do</strong></b></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Assist with the design and development of polymer implantable devices and delivery device tools through design development to manufacturing, consistent with medical devices regulatory and quality requirements.</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Own development and execution of V&amp;V strategies, including protocol authorship, design traceability, and establishment of clear, testable acceptance criteria.&nbsp;</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Design and execute experimental benchtop studies and statistical analyses (e.g., DOE, capability studies) to assess the impact of processing parameters on product performance and variability.</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Interpret data and communicate findings to cross‑functional teams.</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Lead design transfer activities from R&amp;D into manufacturing environments, including preclinical and clinical builds, with a focus on aseptic/sterile processing and process consistency.</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Collaborate with Operations, Quality, and external partners to ensure robust, scalable processes.</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Contribute to design controls and risk management activities, including verification, validation, and FMEAs.&nbsp;</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Manage relevant vendor relationships, including component vendors and external testing.</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Continuously monitor compliance with FDA, ISO 13485, and design control requirements. </span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:12pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">Qualifications</strong></b></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">B.S., M.S., or Ph.D. in Biomedical, Mechanical, Chemical Engineering, or related field</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">5+ years in Class II/III medical device product development or manufacturing&nbsp;</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Experience with:</span></li><li 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and protocol development</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Applied statistics (DOE, regression, capability analysis)</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Risk analysis (FMEA, hazard analysis, fault tree)</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Manufacturing transfer and supplier interaction</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">ISO 13485 and FDA QMSR</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Design transfer for sterile/aseptic processes (preferred)</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Class II/III implantable devices or combination products (preferred)</span></li></ul></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Strong communication, documentation rigor, and cross‑functional collaboration</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Self‑starter with strong problem‑solving skills</span></li><li style=\"color:rgb(0,0,0);font-size:12pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Ability to work on‑site in lab and controlled manufacturing environments (PPE/cleanroom gowning, hands‑on work, lifting up to 25 lbs.)</span></li></ul><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br><span style=\"font-size:10pt;white-space:pre-wrap;\">Applicants must be authorized to work in the United States.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:10pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"font-size:10pt;white-space:pre-wrap;\">Contraline is a Charlottesville-based company working at the forefront of reproductive medicine.&nbsp;We believe that we go further when we go together. We are dedicated to building a diverse, inclusive and authentic workplace. If you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. All backgrounds, identities, and voices are welcomed!&nbsp;</span></p>",
      "company": "<meta><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:18pt;white-space:pre-wrap;\">About Contraline Inc.&nbsp;</strong></b></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"color:rgb(0,0,0);font-size:12pt;white-space:pre-wrap;\">Contraline is a venture-backed medical device company based in Charlottesville, Virginia. The company’s lead product is ADAM™, the world’s first injectable hydrogel designed to provide long-lasting, non-hormonal, and reversible contraception for men. The company aims to use its hydrogel platform technology to address global reproductive health challenges with no solutions and significant unmet needs. The company is well recognized in the field of Contraception and positioned for success.</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><br></p>"
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