Manufacturing Engineer

GxPeople Global; Trowbridge; On-site; GBP 55,000 - 75,000; Full time

Job summary

GxPeople Global is seeking an experienced Manufacturing/Process Engineer for a 12-month fixed term contract in the healthcare technology sector. You will drive process improvements, support V&V at CMOs, and partner with design engineers to optimize manufacturability of instrumentation systems.

Role requires 5+ years in regulated environments with ISO 13485 familiarity, plus hands-on experience in process validation, transfer & scale-up, and QMS documentation.

Qualifications

• 5+ years of experience in a regulated industry with Quality Management Systems (e.g., ISO 13485).
• Proven track record owning and improving manufacturing processes within medical device/diagnostics manufacturing.
• Experience supporting manufacturing transfer, scale-up, and production with CMOs or external partners.
• Strong familiarity with Design for Manufacturability (DFM) and Design for Assembly (DFA).
• Understanding of process validation, in-line testing, and verification/validation (V&V).
• Hands-on approach to process development, troubleshooting, and QMS documentation management.
• Ability to manage projects with minimal supervision.

Responsibilities

• Evaluate manufacturing processes and workflows to identify improvements.
• Support verification and validation activities for manufacturing lines at CMOs.
• Enhance product design for manufacturability and assembly (DFM/DFA).
• Design equipment and systems that reduce production time and costs while improving quality and safety.
• Maintain complete process documentation including reports, BOMs, and specifications.
• Ensure reliable production of products and sub-assemblies to meet quotas.
• Independently manage technical projects using established engineering principles.

Skills

Regulated industry experience

Medical device manufacturing

QMS documentation

Process validation

DFM/DFA

Transfer & scale-up

V&V knowledge

Job description

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.

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