28 days old

Manager/Director Product Development

Common Sensing
Cambridge, MA 02139
  • Job Code
    118682758

Own

  • Manage the Product Development Team and product development process at Common Sensing
    • Mechanical Design, Project Engineers, and Human Factor
  • Accountable for creation and execution of product design development plans
  • Ensure effective gathering of customer, user, regulatory and technical requirements by the product development team
  • Accountable for the Design Control Process, including design verification and validation in accordance with ISO 13485
  • Accountable for the creation of Design History Files and Technical File submissions
  • Recruit for, support, and motivate the product development team.
  • Set and communicate priorities for the product development team in alignment with company objectives

Support

  • Support external project manager with customer technical communications and interfacing
  • Support creation of customer project statements of work, including cost estimates
  • Support the Human Factors Lead in owning the Usability Engineering Process (IEC 62366-1)
  • Support the Systems Engineer in owning the Risk Management Process (ISO 14971) on a project basis
  • Support the Quality Manager as a secondary representative for Common Sensing during external audit from regulatory agencies and notified bodies
  • Support the product development team in promoting mental health care and active rest

Learn

  • Learn Common Sensing's technology and the unique applications for it in improving the experience for people who use injectable medicine
  • Continuous learning towards effective communication, listening, and management excellence

Teach

  • Demonstrate strong verbal and written communication skills
  • Clearly communicate results, conclusions, and recommendations to team members
  • Awareness of value of diversity, and inclusive social practices

<h3>Own</h3> <ul> <li>Manage the Product Development Team and product development process at Common Sensing <ul> <li>Mechanical Design, Project Engineers, and Human Factor</li> </ul> </li> <li>Accountable for creation and execution of product design development plans</li> <li>Ensure effective gathering of customer, user, regulatory and technical requirements by the product development team</li> <li>Accountable for the Design Control Process, including design verification and validation in accordance with ISO 13485</li> <li>Accountable for the creation of Design History Files and Technical File submissions</li> <li>Recruit for, support, and motivate the product development team.</li> <li>Set and communicate priorities for the product development team in alignment with company objectives</li> </ul> <h3>Support</h3> <ul> <li>Support external project manager with customer technical communications and interfacing</li> <li>Support creation of customer project statements of work, including cost estimates</li> <li>Support the Human Factors Lead in owning the Usability Engineering Process (IEC 62366-1)</li> <li>Support the Systems Engineer in owning the Risk Management Process (ISO 14971) on a project basis</li> <li>Support the Quality Manager as a secondary representative for Common Sensing during external audit from regulatory agencies and notified bodies</li> <li>Support the product development team in promoting mental health care and active rest</li> </ul> <h3>Learn</h3> <ul> <li>Learn Common Sensing's technology and the unique applications for it in improving the experience for people who use injectable medicine</li> <li>Continuous learning towards effective communication, listening, and management excellence</li> </ul> <h3>Teach</h3> <ul> <li>Demonstrate strong verbal and written communication skills</li> <li>Clearly communicate results, conclusions, and recommendations to team members</li> <li>Awareness of value of diversity, and inclusive social practices</li> </ul> <p> </p> <img src="https://analytics.click2apply.net/v/JBwyV8cKnqVNhPJVfXjBl"> <br/><br/><h3>Education, Experience, Skills, and Background Requirements</h3> <ul> <li>10+ years of experience product development with medical devices under a quality management system</li> <li>5+ years of experience managing a team</li> <li>Minimum BS degree in engineering or other technically related fields</li> <li>Openness to traveling domestically and internationally on an as-needed basis</li> </ul><p>PI118682758</p>

Categories

Posted: 2020-03-03 Expires: 2020-04-03

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Manager/Director Product Development

Common Sensing
Cambridge, MA 02139

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