Platform Development & Lifecycle - Design (Senior) Engineer

SHL Medical AG seeks a Senior Platform Development & Lifecycle Design Engineer in Switzerland to lead device innovation, manage design engineering activities, and ensure product safety and performance.

The company is looking for a senior engineer to drive the creation of patentable concepts and manage the full product design engineering lifecycle. This role involves coordinating development activities, ensuring compliance with functional and safety standards, and providing post-development support and enhancements for advanced self-injection devices.

Responsibilities

• Generate and develop novel concepts for device innovation.
• Oversee and execute product design engineering tasks throughout the development process.
• Verify that products meet all specified functional and safety criteria.
• Handle maintenance, support, and improvements for designs after the initial development phase.
• Coordinate feasibility studies for combination products involving SHL devices and customer prefilled syringes.
• Assess design input requirements to ensure alignment with performance characteristics.
• Create initiative documents for design inputs, including specifications for syringes/cartridges and hazard identification.
• Develop functional analysis documents and conduct risk management analyses.
• Evaluate syringe performance and execute design analysis through simulation and testing.
• Review usability documentation, such as User Interface Specifications and Instructions for Use.
• Create product drawings and confirm DFMA reviews.
• Conduct design reviews and document meeting minutes.
• Host meetings to review design verification readiness.
• Compile information for submission packages.
• Offer technical guidance to the production team.
• Participate in Non-Conformance Material Review (NCMR) and complaint investigations.
• Lead Root Cause Analysis (RCA) investigations for design-related issues.
• Keep product and risk management documentation, including the Design History File (DHF), current.
• Suggest and evaluate design improvements for manufacturability, cost, and performance.
• Mentor junior engineers to enhance their design capabilities.
• Act as a peer reviewer to identify design flaws early.
• Lead teams to produce designs, project proposals, and execute them effectively.
• Coordinate continuous improvement of design, system, and process.

Requirements

• Experience in product design engineering.
• Knowledge of risk management principles.
• Proficiency in DFMEA.
• Understanding of HIC.
• Skills in design analysis.
• Ability to use simulation tools.
• Experience with testing methodologies.
• Familiarity with DFMA.
• Competence in design verification.
• Knowledge of RCA and CAPA processes.
• Experience in design lifecycle management.

About the company

SHL Medical AG is a global leader in designing, developing, and manufacturing advanced self-injection devices. The company collaborates with top pharmaceutical and biotech firms, driven by a shared commitment to innovation, impact, and growth. The workplace is characterized by a supportive, inclusive, and dynamic culture.

• World-leading provider in advanced self-injection devices.
• Partners with leading pharmaceutical and biotech companies.
• United by a commitment to innovation, impact, and growth.
• Supportive, inclusive, and dynamic workplace.