Our client is currently hiring for a Project Engineer in Marlborough, MA for a contract opportunity.
What you'll do:
As a Lead Project Engineer you will understand and capture the user needs into modified system requirements, and in collaboration with the project manager you will lead and coordinate the efforts of other team members and contributing functions to fulfill the technical deliverables for each project. These projects do not involve new designs per se, rather, the customizations are applied to standard configured XDR bioreactor platform. Typical project duration is 4-to-6 months where the design phase represents, on average, 6-to-8 weeks.
As a lead hardware engineer you will direct and work with mechanical engineers (CAD designers), electrical and automation engineers. Note that this is an individual contributor role.
Generate requirements traceability matrix and ensure that applicable customer requirements (URS) are tracked and fulfilled.
• Overall design responsibility, including regulatory compliance, for the modified bioreactor products.
• Represent client in technical discussions with customers during a project and resolve technical questions with customers, suppliers, or internal personnel.
• Create or modify design specifications documents, generate customer-facing design documentation, lead technical design reviews, review, and approve detailed design outputs.
• Create and/or modify Bill-of-Materials (BOMs) for subsystems and the main instrument.
• Interface directly with suppliers of main subsystems and resolve any design or technical questions or issues.
• Lead design transfer to manufacturing to ensure production-readiness.
• Review and approve product accompanying documentation Turn-Over-Package (TOP)
• Work with the test engineer and ensure correct equipment set-up for Functional Testing & Factory Acceptance Test (FAT)
• Support customer questions/issues during FAT and manage resolution of punch list for any design issues Client.
• Lead and/or contribute to multiple projects/demands simultaneously.
• Interface cross-functionally with Automation, Quality/Regulatory, Service, Manufacturing, Sourcing, Project Management, and Product Management
Who you are:
• Bachelor’s Degree or equivalent in Mechanical, Electrical, Chemical Engineering, or related STEM Major
• Minimum of 3 years of relevant experience and demonstrated broad exposure to HW/SW/Systems design of process equipment with technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)
• Working knowledge and understanding of requirements decomposition.
• Experience with product data management (PDM) software and Bills of Materials (BOMs)
• Experience with design controls and engineering change control
• Familiarity with typical process equipment components such as pumps, pneumatic valves, heaters, transmitters etc.
• Familiarity with electro-mechanical control components, automation, PLCs and process equipment UI
• Experience working in regulated environment.
• Capacity to plan, organize, and complete tasks on time.
• Comfortable with working on many projects in parallel, aggressive timelines and frequent change.
• Customer-oriented mindset, highly organized with excellent analytical, documentation and multi-tasking skills
• Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Knowledge and experience with regulated industries quality systems and relevant regulations such as cGMP, ISO 9001, ISO 13485
• Experience with Upstream Bioprocessing Equipment such as Bioreactors and mixers.
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