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R&D Product Development

Engineering Director, Devices

  • Titel Engineering Director, Devices
  • Functie R&D Product Development
  • Sub functie Multi-Family R&D Product Development
  • Categorie Director, Multi-Family R&D Product Development (PL9)
  • Locatie Lexington, Massachusetts, United States; Malvern, Pennsylvania, United States
  • Gepost
  • Referentie 2406181206W
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Beschrijving

Johnson & Johnson is recruiting for an Engineering Director, Devices located in Malvern, PA, or Lexington, MA.

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/

The Engineering, Director role is part of the global Drug Delivery Systems (DDS) team. The position reports to the Senior Director, Head of DDS located in Malvern, PA (US).

Leads and oversees the development of new and existing combination product with specific focus on development local/implant delivery technologies that leverage the TARIS delivery platform.

Leads and support the development of devices in accordance with the combination product development process (CPDP).

Partner closely with Discovery colleagues within DPDS and directly coordinates with formulation and analytical development teams within the TDS Therapeutic Development & Supply (TDS) organization.

Partner closely with the broader DDS team to investigate and test potential solutions and support the integration of those solutions into existing processes.

Act as subject matter expert within the device development process setting expectations at each stage and coaching/mentoring others in the subject.

Represents the device development function on CMC team and to coordinates directly with Quality, Regulatory, Commercial, Formulation, Drug Product Development (DPD), Analytical Development (AD), Sourcing, other members of DDS and other stakeholders to determine device requirements needed to develop device solutions and the execution of device /combo development.

Represents the device development function on the VCT and to Innovative Medicine Supply Chain (IMSC) team members, supporting development of devices and transfer of processes to production, and collaborate to provide oversight of CDMOs as needed.

Key Responsibilities:

  • Delivers on large components of the strategic plan by translating innovation to business application with technically sound approaches and consideration for customer insights.
  • Drives multiple complex programs and projects which have a regional impact across functions.
  • Highly innovative and insightful engineering leader; engages in strategic idea generation and development of intellectual property; focuses efforts to lead innovative design concepts in packaging, device, and engineering disciplines.
  • Identifies and originates packaging, device or engineering projects, initiatives and/or programs that are critical to business objectives and customer insights.
  • Owns strategy for programs or platforms with key business partners.
  • Participates/leads communities of practice providing expertise is a specific engineering area.
  • Owns the development and validation of program or project budgets and goals.

Kwalificaties

Education:

  • Bachelors degree in mechanical, chemical, biological engineering, or equivalent with minimum of 20 years’ experience, a Master’s degree with minimum of 15 years’ experience or PhD with minimum of 10 years’ experience is required

Experience and Skills:

Required:

  • Experience working within drug and/or device regulated environments and quality systems is required
  • Proven track record in leading complex engineering and technical team(s), with direct and indirect people management experience is required
  • Broad knowledge of manufacturing processes, including injection molding and extrusion of polymers, various assembly methods (e.g., adhesives, ultrasonic welding, etc.) is required
  • Demonstrated project management skills and leadership experience is required
  • Ability to foster team productivity and cohesiveness in a complex matrix environment is required
  • Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures, and dynamics is required

Preferred:

  • Proven knowledge of analytical or biochemistry in a R&D environment is preferred
  • Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in formulation and analytical within drug development processes is preferred

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

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