Manufacturing Engineer - Hardware/Software

Distalmotion

Épalinges, Switzerland

About Manufacturing Engineer – Hardware/Software:

As Manufacturing Engineer you will be integrated in the Global Supply Chain, collaborating closely with the Contract Manufacturing Organization (CMO) and providing electronic and software engineering expertise. You will be responsible for the industrialization of product changes, ensuring a smooth transition from development to full-scale production, while focusing on level 2 issue investigation and resolution, particularly related to test bench and assembly processes. Additionally, you will drive continuous improvement initiatives to enhance operational excellence.

Duties and Responsibilities:

Level 2 Issue Support:

Investigate and resolve hardware and software-related issues encountered on test benches and assembly lines;
Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to identify root causes and implement effective corrective actions.

Industrialization and Operational Excellence:

Lead the industrialization process of product changes, ensuring they are designed for manufacturability and scalable for mass production;
Identify and lead continuous improvement projects, focusing on quality, cost reduction and efficiency;
Develop and optimize process FMEA, test specifications, assembly processes, and production workflows, troubleshooting guides – Support CMO operators related trainings;
Liaise with design and development teams to ensure smooth handover to production;
Work closely with equipment developers to ensure the reliability and performance of test systems – maximize First Pass Yield, minimize Downtime.

Compliance:

Ensure DHR – manufacturing processes, manufacturing BOMs, manufacturing and test specifications – comply with regulatory requirements and company standards;
Support audits and inspections by providing technical input and ensuring proper documentation is available.

Work Experience and Education requirements:

3-5 years of experience in manufacturing engineering, product verification or R&D, preferably in the medical device industry or a similar regulated environment;
Proven expertise in both hardware and software, particularly in resolving technical issues related to test benches and assembly equipment;
Bachelor or Master degree in electrical engineering, embedded software engineering or related field;
Experience in new product industrialization and transferring products from R&D to production is a plus;
Degrees or certifications in Manufacturing, Operations, or Continuous Improvement (e.g., Lean, Six Sigma) are a plus.

Knowledge, Skills & Abilities required:

Strong troubleshooting and problem-solving skills, with the ability to quickly identify and resolve issues;
Proficiency in programming languages and software tools commonly used in embedded systems, test benches and manufacturing systems;
Excellent communication and strong prioritization skills, with the ability to work effectively in cross-functional teams;
Familiarity with regulatory requirements (like ISO 13485), Good Manufacturing Practices (GMP), and associated activities;
Ability to work in a fast-paced manufacturing environment and handle multiple projects simultaneously;
Professional oral and written English; French and German a nice to have.

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