At a Glance
- Tasks: Design and improve manufacturing processes in the medical device industry.
- Company: Innovative healthcare technology company focused on expanding access to care.
- Benefits: Gain valuable experience in a regulated industry with potential for career growth.
- Other info: Collaborate with external partners in a dynamic and supportive environment.
- Why this job: Make a real impact in healthcare by enhancing production efficiency and quality.
- Qualifications: 5+ years in regulated industries, strong technical skills, and project management experience.
The predicted salary is between 60000 - 60000 £ per year.
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.
Manufacturing Engineer in Trowbridge employer: GxPeople Global
Join a forward-thinking healthcare technology company that prioritises innovation and employee development. With a strong commitment to quality and regulatory standards, we foster a collaborative work culture where your contributions directly impact patient care. Located in a vibrant area, we offer competitive benefits, opportunities for professional growth, and the chance to be part of a mission-driven team dedicated to improving lives through advanced medical devices.