Posted to MedZilla on 10/14/2019


Takeda Pharmaceuticals

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


 
 

Primary Duties

Early patient identification and therapy monitoring are key to assure optimal patient outcomes. The Takeda Medical Devices Center of Excellence (MD CoE) based in Lexington, Massachusetts allows Takeda to explore how next generation therapeutics, emerging technologies, data analytics and new patient care models can improve patient health while reducing clinical, psycho-social and economic burden. 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 our global medical, commercial, device and drug product development partners, the MD CoE organization is responsible for driving early stage device delivery system and diagnostics initiatives.

Key activities include:

  • Contribute to the development of patient diagnostics point of care devices and testing services programs in support of patients with rare genetic diseases as well as assessment of new/emerging diagnostics methods/techniques with potential application to Takeda products;
  • Engage with external partners and internal stakeholders (Device CoE, Regulatory, Mfg., Drug Development, QC, Medical, Commercial Legal etc.);
  • Be recognized as an internal subject matter expert in diagnostic systems technologies development;
  • Collaborate with commercial and/or clinical partners in user research efforts to uncover unmet user needs;
  • Support business or project case development for project justification and approval by governing bodies.
  • Support Target Device Profile (TDP) for technology development projects;
  • Monitor market and competitive intelligence for impact on device and patient services development strategies;
  • 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

30% (25-35%): Project execution with core team & development partner(s)

25% (20-30%): Feasibility testing and assessment of PoC product concepts

15% (10-20%): Diagnostics patient support systems technology exploration

15% (10-20%): Development of core documentation

15% (10-20%): User Research support

Education and Experience Requirements

Required:

  • BS in relevant scientific or engineering area of study (typically, biochemistry, immunology, systems or biomedical engineering) with minimum five (5) years of experience in diagnostic assay and/or systems development.

or

  • MS in relevant scientific or engineering area of study (typically, mechanical, plastics or biomedical engineering) with minimum (3) years of experience in diagnostic assay and/or 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 in laboratory device development and able to work with biological samples such as whole blood, plasma, urine etc.

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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