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Senior Engineer – Biotech Drug Delivery Systems (JP7758)

Cambridge, MA · Biotech/Pharmaceutical
Job Title:  Senior Engineer – Biotech Drug Delivery Systems (JP7758)
Location: Cambridge, MA. (Fully remote)
Employment Type:  Contract
Business Unit: Device Strategy Technology Assessment
Duration: 1 year with likely extension or conversion to FTE.
Posting Date: 10/6/2020
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our client, a leading global biopharmaceutical company.

Ideal candidate: BS in Engineering (5 years experience) OR Masters Degree (3+ years experience) within medical device

Job Description:
Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
  • Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
  • Create and assess product requirements to determine technical coverage and proper integration different subsystems.
  • Create and execute to project plans and schedules
  • Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
  • Provide deep technical assistance for junior engineers.
  • BS in Engineering and previous experience in a medical device industry - 5 years current experience with engineering processes and procedures.
  • Led projects from development through the 510k and PMA approval process (or equivalent).
  • Strong background in engineering and commercialization of mechanical and electro-mechanical medical devices.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Experience in drug/device combination product design and development
  • Familiar with the following standards:
    • Quality System Regulation, 21CFR820 o Risk Management,  ISO 14971
    • EU Medical Device requirements � Council Directive 93/42/EEC Medical Electrical Equipment EN 60601
  • Small scale device assembly experience.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Strong problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment. 
Why is the Position Open?
Additional workload on the team
Top Must-Have Skill Sets:
  • Engineering design
  • Medical device development experience
  • Experience with drug delivery devices
Day to Day Responsibilities:
Contribute to combination product development programs as technical lead.

Employee Value Proposition:
Work on combo products, medical device with the drug. client's strong therapeutic pipeline
Red Flags:
Long pauses in employment history

Interview process:
All via skype (phone).

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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