Senior Engineer – Biotech Drug Delivery Systems (JP7758)
Cambridge, MA. (Fully remote)
Device Strategy Technology Assessment
1 year with likely extension or conversion to FTE.
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
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.
Why is the Position Open?
- 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.
Additional workload on the team
Top Must-Have Skill Sets:
Day to Day Responsibilities:
- Engineering design
- Medical device development experience
- Experience with drug delivery devices
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
Long pauses in employment history
All via skype (phone).
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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.