Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Device Engineering Manager in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Device Engineering Manager working on the R&D Quality team team, you will be empowered to be the subject matter expert of drug delivery devices, and a typical day will include:
- The Quality Device Engineering Manager will liaise with technical groups in the development of drug delivery devices. Scope includes a wide range of devices, such as: needle protection systems, fluid transfer devices, pen injectors and automatic pen injectors.
- Partner with technical teams to ensure successful device development of these devices. The Quality Device Engineering Manager will work closely with team members to develop compliant detailed engineering specifications, device design and development, support verification, validation and regulatory submissions of the combination devices.
- The role of the Quality Device Engineering Manager is to work within a cross functional organization to provide Quality oversight, ensure compliance, utilize technologies and methodologies that support robust device development.
- Work cross functionally with individuals and project teams in Marketing, Operations, Technical Development and other functions as necessary.
- Support CMO site selection, product transfers, device commercialization, new technology evaluation and development product produced at CMO s.
- Assist in the creation and assessment of product requirements to determine technical coverage and proper integration of different subsystems.
- Identify deliverables and establish documentation required for project support in accordance with applicable SOP s, standard and design controls.
- Review, execute and approve requirement documents, design documents, specifications, development plans, characterization plans, verification and validation plans (including human factor studies) and test protocols, reports and other related product development documents for assigned products.
- Review and approve process validation reports from CMO s to assure they meet regulatory requirements and support regulatory filings.
- Provide oversight of design verification and validation performed by CMO s and assure design or the device and packaging are verified.
- Troubleshoot and direct the resolution of complex quality issues during design and development and during technical transfer.
- Participate in the resolution of complaints.
- Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.
- Conduct FMEAs; assist in writing Risk Management Report.
- Develop and maintain trace matrices during the development process.
- Create and update any quality systems documents related to combination products development
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors required in a technical field relating to engineering or science
- Minimum 5 years experience with engineering processes and procedures in the medical device industry dealing with product development.
- Minimum 3 years experience in device product development engineering
- Experience with software tools used for Requirement Management and Traceability (such as DOORs, Test Track, etc.)
- Product design/development (design controls) experience from concept to post launch for Europe & US submissions.
- Experienced in protocol and report writing, process and test development, prototyping, design verification. DOE/SPC process optimization and validation (IQ, OQ, PQ) and risk management activities.
- Good communication skills, team player and ability to multi-task.
- Promotes process improvement
- Proficient in Microsoft Office, Visio and electronic trace matrix software.
- Knowledge of quality and statistical analysis is required.
we are driven to improve people's lives
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