Mechanical Engineer - Cost & Product Improvement

Arbeitnow; Épalinges; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Distalmotion seeks a Mechanical Engineer for the Instruments – Product Improvement team to drive design optimization, cost reduction, and manufacturing efficiency of the surgical system instruments.

You will apply CAD (SOLIDWORKS), DFx, and Design Control, collaborating with Ops, QA, RA, and manufacturing to implement robust changes.

You’ll investigate clinical complaints, lead root cause analyses, and ensure compliance with ISO 13485, FDA 21 CFR 820, and MDR.

Qualifikationen

• Mechanical, microtechnology engineering degree (BSc or MSc).
• At least 5 years in medical device or highly regulated environment.
• Proficiency in CAD; SOLIDWORKS preferred.
• Design for Manufacturing experience for plastics/metals.
• Knowledge of Design Control and change management workflows.
• Strong analytical, problem-solving, and communication skills.
• Languages: French and English.

Aufgaben

• Specify design, prototype, and implement mechanical components and fixtures with DFM/ DFA/ DFC.
• Identify and execute cost reduction opportunities without compromising quality or safety.
• Collaborate with manufacturing (prototyping to industrialization) and testing teams.
• Perform impact analysis on manufacturing processes and unit costs.
• Define requirements and test protocols; supervise design verification.
• Lead root cause analysis for clinical complaints and non-conformities.
• Ensure compliance with ISO 13485, FDA 21 CFR 820, MDR.

Ausbildung

Mechanical / microtechnology engineering degree (BSc or MSc)

Tools

SOLIDWORKS

Jobbeschreibung

Distalmotion seeks a Mechanical Engineer for the Instruments – Product Improvement team to drive design optimization, cost reduction, and manufacturing efficiency of the surgical system instruments.

You will apply CAD (SOLIDWORKS), DFx, and Design Control, collaborating with Ops, QA, RA, and manufacturing to implement robust changes.

You’ll investigate clinical complaints, lead root cause analyses, and ensure compliance with ISO 13485, FDA 21 CFR 820, and MDR.