Posted to MedZilla on 10/14/2019


Takeda Pharmaceuticals

US-MA, Head, Development Device Engineering SR0040538-MZ


 
 

Primary Duties

The Head of Development Devices Engineering is responsible for all engineering aspects of device development from early concept (exploratory) to formal development (Design Control) of devices and combination products through tech transfer / launch. The function is heading a team of about 35 engineers and technicians.

This position aims to develop new devices and combination products to support the innovative pipeline of Takeda with a priority on speed-to-patient, product quality, and cost. It involves directing the internal development and external development activities including the qualification and implementation of original IP or the implementation of off-the shelf solutions when adequate.

This role works very close with the other device functions, including human factors, device strategy and program stewardship, commercial device engineering, supplier relationship management, quality, regulatory affairs, packaging engineers and drug product groups (e.g. in use testing) to coordinate all aspects needed to ensure best in class development that meets current regulatory requirements and patient needs.

This role will be involved in development, submission and launch activities; activities include: assessments & due diligence, design, development, risk assessment, testing, specifications, supplier interactions and others. Additional responsibilities include support for complaint investigations or manufacturing issues.

Responsibilities

Primary (60%)

  • Growth and development of a team of about 35+ people in the area of device development and testing. Strong, proven communication and leadership capabilities are required
  • Oversight on all engineering development activities for devices and combination products including submission activities
  • Support of Takeda pipeline activities by developing innovative new devices and combination products following a multi-generation product approach
  • Technology Development and early concept development
  • Leveraging existing off the shelf solutions where appropriate
  • Accountable for following Design Control in accordance with current regulatory expectations for development activities
  • Ensure creation of robust DHF and smooth Design Transfers
  • Testing support for all device related functions.
    • Ensure that test lab and other design & development activities are in compliance with GLP, GDP.
  • Ensure test methods are validated when used for Design Control related activities
  • Ensure proper and compliant tech transfer of developed device projects to Commercial Device Engineering products

Secondary (25%)

  • Active Stakeholder management, partner with other device functions
  • Support continuous improvement activities
  • 2nd line of support for Complaints and resolution of technical challenges for commercial product
  • Build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, CMOs, Product Strategy Leads, Quality, Procurement, Regulatory Business Development, Research & Development and Manufacturing Teams.
  • Mentoring Engineers within Medical Devices as needed

Tertiary (15%)

  • Recruitment and management of external resources, such as, Consultants and Contractors, as needed to deliver projects.
  • Remain current with standards and regulatory guidelines
  • Self-driven, independent work style
  • Support due diligence activities as needed.
  • Advance procedures and processes (e.g. SOPs) and participate in continuous improvement activities
  • Advance internal capabilities as required

Education and Experience Requirements

  • Requires a master s degree (Ph.D. preferred) in an engineering, scientific/technical discipline with a minimum of 15 years related experience. Applies expert knowledge of engineering, scientific/technical principles and concepts in managing technical programs
  • Strong leadership and people management skills
  • Experience managing large teams (30+) within a matrixed organization
  • Ability to engage with all relevant stakeholders
  • Solid understanding of mechanical and electromechanical devices
  • Understanding of software devices and connectivity is a plus.
  • Strong expertise in design control for devices and combination products
  • Strong experience in all stages of product development including global product launches and the associated CMC regulatory requirements.
  • Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred.
  • Ability to simultaneously manage multiple projects of variable complexity.
  • Understanding of Pharmaceutical landscape; pharmaceutical drug delivery device experience highly preferred.

Other Job Requirements

Travel of up to 25% may be required

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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