Manufacturing Engineer

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

* Process Evaluation & Continuous Improvement:
Evaluate manufacturing processes and workflows to identify improvements by collaborating with line operators, component vendors, and key suppliers.

* 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.

* Design for Manufacturability:
Work closely with design engineers to enhance product design for ease of manufacturing and assembly (DFM/DFA).

* Efficiency & Safety:
Design equipment and systems that reduce production time and costs while improving overall quality and safety.

* Quality & Documentation:
Maintain complete process documentation—including technical reports, process capability studies, BOMs, and process specifications—in line with QMS requirements.

* Production Reliability:
Ensure products and sub-assemblies are manufactured reliably and perform consistently to meet performance quotas.

* Project Management:
Independently manage technical projects using established engineering principles.

Required Qualifications & Experience

* Regulated Industry

Experience:

5+ years of experience in a regulated industry where Quality Management Systems (e.g., ISO 13485) are essential.

* Medical Device & Diagnostics:
Proven track record owning and improving manufacturing processes within medical device or diagnostics manufacturing.

* Transfer & Scale-Up:
Demonstrated experience supporting manufacturing transfer, scale-up, and production in collaboration with CMOs or external partners.

* Technical Skills & Assembly:
Strong familiarity with Design for Manufacturability (DFM), Design for Assembly (DFA), and assembly methods relevant to instrumentation/electromechanical systems.

* Process Validation:
Solid understanding of process validation, in-line testing strategies, and system verification/validation (V&V).

* Troubleshooting & QMS:
Hands-on approach to process development, experimentation, root-cause troubleshooting, and QMS documentation management.

* Communication & Autonomy:
Strong verbal/written communication skills with the ability to manage projects with minimal supervision