Elevaris Medical Devices
Project Engineer
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Senior Project Engineer – Medical Device Development (NPI)
About the Role
Elevaris Medical Devices is a Contract Development and Manufacturing Organization for industry-leading, multinational healthcare companies, global Original Equipment Manufacturers (OEMs), and emerging technology companies. As one of the world’s leading manufacturers of made-to-spec procedural needles, the company also specializes in precision micro-components, complex tubular components, and sub-assemblies. Elevaris also distributes pharmaceutical products, surgical instruments, and medical supplies.
This previously Spectra Medical Devices (founded in 1995), rebranded to Elevaris Medical Devices following the acquisition of UK-based XL Precision Technologies in 2021. Today, it represents a new era of precision medical device development and manufacturing capabilities.
We are seeking a Senior Project Engineer to provide comprehensive engineering and project support across the full lifecycle of development and pre-production (NPI) projects. This role ensures the successful planning, coordination, and execution of technical activities, including:
- RFQ processing
- Cost analysis and feasibility assessments
- Commercial and contractual reviews
- Cross-functional collaboration for on-time, on-budget, quality-driven outcomes
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The ideal candidate will manage Bill of Materials (BOMs), procurement, and validation documentation, while supporting continuous improvement initiatives and maintaining compliance with quality and validation standards.
Responsibilities
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Support the end-to-end lifecycle of development and pre-production (NPI) projects, including:
- Processing Request for Quotations (RFQs)
- Conducting material costings and methodology feasibility discussions
- Completing cost cards for commercial review
- Reviewing Purchase Orders (POs) and sales orders/contracts
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Coordinate and monitor assigned engineering projects, ensuring:
- Accurate scheduling, procuring, and execution
- Alignment with client needs and specifications
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Develop and maintain:
- Bills of Materials (BOMs)
- Procurement processes
- Validation documentation (PPAP & custom validation plans)
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Engage in client interactions, interpreting requirements and ensuring order acknowledgment and agreement.
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Create specifications for project equipment timing plans to meet customer deadlines.
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Collaborate with senior engineers to:
- Improve project methodologies
- Ensure profitability and efficiency
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Conduct process reviews, initiating corrective actions as needed.
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Design and implement project metrics frameworks, collecting relevant data for analysis.
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Specialist Project Requirements
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Prepare and manage:
- Process Flow Diagrams (PFDs)
- Failure Mode & Effects Analysis (FMEA)
- Custom validation protocols, PPAP, and compliance plans
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Adhere to quality and regulatory standards within medical device manufacturing.
Requirements
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Qualified engineer (degree/diploma) with expertise in:
- NPI / pre-production projects
- Medical device industry knowledge
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Previous experience in:
- Procurement / BOM management
- Cost analysis and commercial reviews
- Project coordination & adherence to timelines
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Strong analytical and problem-solving skills, with an ability to:
- Negotiate technically and commercially with clients
- Implement continuous improvement methodologies
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Proficiency in:
- Microsoft Office / project management tools
- Industry-standard medical device documentation
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Ability to train and upskill as needed for unfamiliar tasks.
Benefits
- Opportunities for additional development support and training.
- Access to an innovative, customer-focused environment.
- Working with cutting-edge medical device technologies.
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