Posted to MedZilla on 5/19/2019


Takeda Pharmaceuticals

US-MA, Sr. Engineer, Diagnostic Systems Technology Development SR0034595-MZ


 
 

Job Summary:

Early patient identification and therapy monitoring are key to assure optimal patient outcomes. Our team shares a passion for challenging conventional wisdom and creating an environment that appreciates the risk-reward aspects of developing breakthrough concepts. Working closely with commercial, device and drug product partners, the DSTD group is responsible for driving early stage device/delivery system initiatives to entry to development, and leading the effort in point-of-care diagnostics.

Key activities include:

  • Contribute to the identification and assessment of new/emerging diagnostics methods/techniques and technologies with potential application to Takeda products; support concept realization through prototyping and feasibility and transfer to development;
  • Engage with external partners and internal stakeholders (BU s, Regulatory, Mfg, Development, QC, Medical, etc.).
  • Be recognized as an internal expert in diagnostic systems technologies;
  • Collaborate with commercial and/or clinical partners in user research efforts to uncover unmet user needs;
  • Support business case development for project justification and approval by governing bodies;
  • Support development of Target Device Profile (TDP) for technology development projects;
  • Monitor market and competitive intelligence for impact on device strategy;
  • Identify development partners/supplier and nurture relationships through contracting.
  • Ensure work and team activities are aligned with all relevant quality, regulatory, HSE, GLP, GMP and design control requirements;
  • Participate in internal and external technical reviews, as required;
  • Lead definition of system/product requirements, specifications, solution definition, trade-off analysis;

Responsibilities:

  • 25% - Feasibility testing and assessment of product concepts
  • 15% - Diagnostics systems technology exploration
  • 30% - Project execution with development partner(s)
  • 15% - Development of core documentation
  • 15% - User Research support

Education and Experience Requirements:

Required:

  • BS/BEng in relevant engineering or scientific area of study (typically, biophysics, biochemistry, mechanical, plastics, systems or biomedical engineering) with minimum five (5) years of experience in diagnostic systems development.
  • or
  • MS in relevant engineering or scientific area of study (typically, mechanical, plastics or biomedical engineering) with minimum (3) years of experience in diagnostic systems development.

Preferred:

  • Experience with point-of-care diagnostic systems;
  • Experience with companion/complementary diagnostics;
  • Demonstrated experience in performing concept prototyping, feasibility testing and assessments;
  • Experience with regulatory requirements (US, EU, Japan etc.) of IVD product approvals;
  • Experience with device testing in biohazard labs and able to work with biological samples such as whole blood, plasma, urine etc.

Key Skills, Abilities, and Competencies:

  • Demonstrated expertise in diagnostic methods, instrumentation and devices;
  • Is able to critically evaluate opportunities and assess risks;
  • Is able to work collaboratively;
  • Has excellent written and oral communication skills; is able to tailor communications for the audience; can communicate complex topics to a lay audience;
  • Is able to think creatively and offer solutions that may not be obvious;
  • Is able to influence decision-making;
  • Understands how user needs drive requirements;
  • Is able to estimate activities and resources required to support a project;
  • Takes initiative and is able to progress activities with minimum of oversight.

Complexity and Problem Solving:

The incumbent will prototype and test product concepts with feasibility and development partners, and in conjunction with commercial, develop Target Device Profiles (TDPs) and support project approval and entry to the next stage of development.

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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