Contract Type: 12-Month Fixed Term Contract (FTC)
Industry: Healthcare Technology / Medical Devices
About the Role
Join an innovative healthcare technology and diagnostics company dedicated to expanding access to care through rapid, accurate point-of-care testing platforms.
We are seeking a Manufacturing Engineer (Instrumentation) for a 12-Month Fixed Term Contract (FTC). In this role, you will design, implement, monitor, and maintain manufacturing processes and work instructions within the medical device industry. You will play a vital role in evaluating workflows, collaborating with external partners, and scaling production while ensuring strict adherence to regulatory standards.
Key Responsibilities
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Process Evaluation & Continuous Improvement: Evaluate manufacturing processes and workflows to identify improvements by collaborating with line operators, component vendors, and key suppliers.
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CMO & V&V Support: Support verification and validation (V&V) activities for manufacturing lines at CMOs, ensuring appropriate testing suites and in-line process controls are implemented.
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Design for Manufacturability: Work closely with design engineers to enhance product design for ease of manufacturing and assembly (DFM/DFA).
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Efficiency & Safety: Design equipment and systems that reduce production time and costs while improving overall quality and safety.
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Quality & Documentation: Maintain complete process documentation—including technical reports, process capability studies, BOMs, and process specifications—in line with QMS requirements.
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Production Reliability: Ensure products and sub-assemblies are manufactured reliably and perform consistently to meet performance quotas.
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Project Management: Independently manage technical projects using established engineering principles.
Required Qualifications & Experience
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Regulated Industry Experience: 5+ years of experience in a regulated industry where Quality Management Systems (e.g., ISO 13485) are essential.
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Medical Device & Diagnostics: Proven track record owning and improving manufacturing processes within medical device or diagnostics manufacturing.
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Transfer & Scale-Up: Demonstrated experience supporting manufacturing transfer, scale-up, and production in collaboration with CMOs or external partners.
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Technical Skills & Assembly: Strong familiarity with Design for Manufacturability (DFM), Design for Assembly (DFA), and assembly methods relevant to instrumentation/electromechanical systems.
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Process Validation: Solid understanding of process validation, in-line testing strategies, and system verification/validation (V&V).
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Troubleshooting & QMS: Hands-on approach to process development, experimentation, root-cause troubleshooting, and QMS documentation management.
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Communication & Autonomy: Strong verbal/written communication skills with the ability to manage projects with minimal supervision
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