OverviewJob Title: Senior Engineer, Biotech Combination Products (JP*****C)Location: Cambridge, MA.
OR Thousand Oaks, CA.Business Unit: Pre-filled Syringes and Lyo Kit PlatformsEmployment Type: ContractDuration: 18+ months (with possible extensions)Rate: $45 - $51/hour W2Posting Date: 09/13/2023Notes: Only qualified candidates need apply.
Onsite, with some WFH flexibility.3
Key Consulting is recruiting an Senior Engineer, Combination Devices for a consulting engagement with our direct client, a leading global biotechnology company.Job DescriptionIdeal candidate: Minimum of 1 YOE project managing experience.
5-10 YOE in Engineering with background in med device, biotech, (Aero and Auto would also be considered).
Bachelors or Masters Preferred.
Preferred systems experience: Solid works, CAD, SmartsheetResponsibilitiesLead and support the Prefilled syringe combination product platform team in both development and commercial lifecycle of prefilled syringe (PFS) configurations.
Experience leading and managing project timelines and initiatives while reporting out to management.
Scope includes a the full range of PFS devices and variants, such as; needle protection systems and different delivery volumes.
The qualified candidate will lead technical teams to ensure successful device development of these mechanical devices.
The Senior Engineer will work closely with team members acting as a project manager to develop detailed timelines for ensuring engineering specifications, device design & development, verification, validation, and regulatory submissions of these devices are completed on time.Top Must Have Skill Sets: Project Management; Technical understanding of design controls; Device Engineering experienceDay to Day ResponsibilitiesSupporting platform and product development teams by acting as a project manager to ensure timelines and delivery dates are met.




Providing technical support and insights to team members and leading platform initiative projects.Create and execute project plans and schedules; responsible for ensuring team meets project timelinesWork cross-functionally with Marketing, Operations, and Development teamsCreate and assess product requirements to determine technical coverage and proper integration of different subsystemsSupport development, execution, and review of design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projectsProvide deep technical assistance for junior engineersBasic QualificationsBS in Engineering and previous experience in a medical device industry5-10 years current experience with engineering processes and proceduresProject Management experienceStrong background in engineering and commercialization of mechanical medical devicesExperience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEAProduct design/development (design control) from concept to post product launchExperience in drug/device combination product design and developmentStrong problem solving, risk assessment, and risk management skillsMust be capable of working on multiple projects in a deadline driven environmentInterview ProcessInitial Phone screenings and then Webex interviews with a panel of 3-6 team members.Series of 1:1 interviewsApplicationWe invite qualified candidates to send your resume to .
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📌 Senior Engineer, Biotech Combination Products (Jp11782C) (Western Australia)
🏢 3key Consulting
📍 Western Australia