Senior Engineering Manager

Company: Disability Solutions
Location: Lexington
Posted on: October 4, 2024

Job Description:

Johnson and Johnson is currently seeking a Senior Engineering Manager.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.Essential Job Duties and ResponsibilitiesThe Senior Engineering Manager, Drug Delivery Systems (DDS), Johnson & Johnson Innovative Medicines, represents the device function on the CMC team for development programs that they are assigned to. For some projects, the Senior Engineering Manager is in the lead device role, and sometimes they are in a supporting role. The function entails working with Quality, Regulatory, Commercial, Formulation, Drug Product Development (DPD), Analytical Development (AD), Sourcing, other members of DDS and other stakeholders to understand device requirements, investigating suitable device options (considering in sequence Janssen platform devices, other commercially available devices, and devices requiring significant development), to coordinate the development of an appropriate device strategy for the program and to execute on the development of the device strategy. The Senior Engineering Manager also works closely with internal or external manufacturers to ensure manufacture of combination product clinical trial material as needed to meet the clinical demand schedule and the manufacture of development devices and combination devices to meet the overall product development plan.Principal responsibilities:

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• Follow the Clinical Design Control Process (CDCP, Phase 0/1/2) or Combination Product Development Process (CPDP, Phase 3/Launch) to develop the device(s) for clinical studies and commercial launch.
• Responsible for the manufacture of combination product clinical trial material meeting the clinical demand schedule.
• Responsible for the manufacture of combination product development material as needed to advance the program and meet CDCP, CPDP and CMC stage gate process as applicable\r\rAs part of these responsibilities, the Senior Engineering Manager:
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  • Puts together budgets and schedules for device development and communicates this information to the CMC
  • Is expected to be familiar with available drug delivery devices and external device partners and manufacturers
  • Works closely with external device partners and manufacturers to develop, test and manufacture devices/combination products, and ensure the devices/combination products will be available for testing, clinical studies, and commercial launch
  • Works closely with Drug Product Development (DPD) and Analytical Development (AD) counterparts as required to support combination product development
  • Works with external manufacturers, Janssen Supply Chain (JSC) and/or Clinical Supply Chain (CSC) to coordinate manufacturing and supply for clinical studies and commercialization
  • Participates in planning and execution of clinical studies as needed to ensure the combination product and devices are used properly, helping to ensure the best possible safety and efficacy outcomes
  • Support Human Factors testing as needed to evaluate device and combination product usability
  • Supports regulatory submissions by providing source documentation and information as needed
  • Writes documents required to comply with the CPDP and Phase 1/2 Clinical Support Process, and ensures that these documents are entered into and approved in the document control system, as appropriate\r\r

Keywords: Disability Solutions, Malden , Senior Engineering Manager, Engineering , Lexington, Massachusetts