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Director, Combination Product Development and Human Factors Engineering
kaleo
WorldwideRemote2d ago
- Seniority
- Lead
About the role
<p><strong>This is a remote opportunity with occasional travel, estimated at less than 25%.</strong></p>
<p>Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind.</p>
<p><span data-contrast="auto"></span><span data-contrast="auto"></span><span data-contrast="auto">The <strong><span data-teams="true">Director, Combination Product Development and Human Factor Engineering</span></strong> is responsible for managing the development</span><span data-ccp-props="{}"> of </span><span data-contrast="auto">new combination products including design, development, and human factor studies through design transfer into manufacturing. The individual should be involved in building Kaleo’s intellectual property portfolio development. The Director will support the senior leadership team with critical information to make informed decisions on the selection of key partners, risks, and identification of critical milestones (budgeting, R&D build strategy, etc).</span><span data-contrast="auto"></span><span data-ccp-props="{}"> </span></p>
<p><span class="ContentControlBoundarySink SCXW76625767 BCX8" lang="EN-US" data-contrast="none"></span><span class="ContentControl SCXW76625767 BCX8"><span class="ContentControlBoundarySink SCXW76625767 BCX8" lang="EN-US" data-contrast="none"></span><span class="TextRun SCXW76625767 BCX8" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW76625767 BCX8">This </span><span class="NormalTextRun SCXW76625767 BCX8">individual </span><span class="NormalTextRun SCXW76625767 BCX8">will need to develop strong relationships with external partners to ensure completion of all aspects of device/drug development and support of Human Factor stud</span><span class="NormalTextRun SCXW76625767 BCX8">i</span><span class="NormalTextRun SCXW76625767 BCX8">es</span><span class="NormalTextRun SCXW76625767 BCX8"> from</span><span class="NormalTextRun SCXW76625767 BCX8"> planning </span><span class="NormalTextRun SCXW76625767 BCX8">to </span><span class="NormalTextRun SCXW76625767 BCX8">execution. Internal interactions with Business Development, Manufacturing, and Regulatory Affairs provide opportunities to expand knowledge and make an impact on business development and post marketing activities.</span></span><span class="ContentControlBoundarySink SCXW76625767 BCX8" lang="EN-US" data-contrast="none"></span></span><span class="EOP SCXW76625767 BCX8" data-ccp-props="{}"> Key relationships to this position include Regulatory Affairs, External Partners (Suppliers, CMO and CDMO), Legal, Supply Chain, and Manufacturing.</span></p>
<p><strong>As <span data-teams="true">Director, Combination Product Development and Human Factor Engineering</span><span data-contrast="auto"> </span>you will:</strong></p>
<ul>
<li><span data-contrast="auto">Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development in accordance with Kaleo’s Quality System and 21 CFR 820.30/ISO 13485</span><span data-ccp-props="{}"> </span></li>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Lead and responsible for human factor engineering activities as per the regulatory guidelines</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Work with design, development and manufacturing partners to ensure program execution for the development of Kaleo’s drug delivery devices stay on timeline and within approved budget</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Execute Risk Management Programs and Analyses in accordance with Kaléo's Quality System. Utilize Risk Analyses tools including DFMEA, UFMEA and PFMEA in accordance with ISO14971:2019</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Provide leadership for the new products in device design, development, industrialization, stability and pilot clinical activities, execution of design controls and development documentation activities</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Help build Kaleo’s intellectual property portfolio</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Manage project and program budgets and timelines effectively</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Author and review regulatory submissions (as needed)</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Responsible for reporting progress, risks, and opportunities to senior management on an ongoing basis to ensure good progress on all development portfolio programs</span><span data-contrast="auto"></span><span data-ccp-props="{}"> </span></li>
</ul>
<p><strong>A successful <span data-teams="true">Director, Combination Product Development and Human Factor Engineering</span><span data-contrast="auto"> </span>will demonstrate:</strong></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto"></span><span data-contrast="auto">Self-motivated and confident with excellent personnel management skills, organizational skills, analytical abilities, and problem-solving techniques</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Strong technical abilities while being an effective leader</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Must demonstrate initiative, exercise good judgment, and have the ability to achieve results through others</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Strong analytical skills with the ability to creatively solve complex problems</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Excellent verbal and written communication skills when interacting with internal stakeholders at all levels of the organization and external partners, facilitating strong working relationships</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Focused attention to detail</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Ability to work collaboratively and cross-functionally when opportunity arises while holding the team to high standards of excellence</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Display a tenacity to move major initiatives forward with a focused effort and clear set of business goals</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Adept at integrating input from various functional areas and bringing people together to achieve results</span><span data-contrast="auto"></span><span data-ccp-props="{}"> </span></li>
</ul>
<p><strong>To be considered for this position, you must have:</strong></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Bachelors, Masters, or PhD in a technical field related to Product Development or Industrialization (Biomedical Engineering, Mechanical Engineering, Material engineering, Systems Engineering preferred)</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Patient centric drug/device combination product development experience</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Minimum 10+ years of medical device development experience, with experience in managing external CMO’s</span></li>
<li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"></span><span data-contrast="auto">Experience in design controls, risk management and ISO 13485 </span></li>
<li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Minimum 5+ years of managing human factor engineering studies (formative and summative) </span></li>
<li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335551500":0,"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Demonstrated record of accomplishments preferred (e.g., issued US patents, device concept to launch, approved drug/device combination products)</span><span data-contrast="auto"></span><span data-ccp-props="{}"> </span></li>
</ul>
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