(Senior) Design Engineer

November 21, 2024 Full Time Zug Switzerland

Senior) Design Engineer

SHL Medical is a world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide.

Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs.

Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Overview :

The Senior Design Engineer develops mechanical and electro-mechanical drug delivery devices for mass production in a quality management system compliant to US FDA QSR sub-system structure and ISO 13485 clauses.

The Senior Design Engineer collaborates closely with systems engineers, project managers and subject matter experts from adjacent departments like process development, testing & simulation and quality.

The scope of the development spans from ideation, over preliminary design, design implementation to design verification.

Important aspects are innovation, requirements engineering, subsystem analysis and architecture, concept development and selection, design analysis, design for manufacturing and assembly and product specification.

Responsibilities :

• coordinate and execute mechanical design tasks in cross functional teams according to SHL’s research & innovation and product development processes
• ensure innovative and technically correct concepts and product solutions for safe and effective design
• deliver technical solutions for problem statements and provide fact- / data-based overview with conclusions for decision making
• create 3D Models with resilient-CAD-modelling-method and technical drawings and ensuring correctness of all relevant manufacturing information
• forecast design robustness with tools / methods like Tolerance Analysis, Calculations / Simulations, Engineering tests, etc.
• identify and assess failure modes and mitigate design risks
• ensure development work is carried out according to the principles of Design for Assembly and Design for Manufacturing (DFA / DFM) and align with responsible downstream departments
• ensure correct product specifications and design & development documentation according to SHL processes
• plan project related design and development activities and align with Project Manager and Line Manager
• execution of design and development projects and coordinate with cross-functional teams and stakeholders
• plan and align the design scope of development projects and coordinate with cross-functional teams and stakeholders
• drive design activities to comply with agreed timelines, budgets and scope
• ensure on-time completion of activities in accordance with the project plan,
• contribute to and lead internal projects or initiatives (e.g. Lab work, innovation days, lessons learned etc.)
• share knowledge and support skill development of talents within product development organization

Minimum Requirements :

• 6 years of experience in product development
• advanced CAD skills
• Creativity techniques, advanced problem solving skills, self-reliant
• Good planning and controlling skills for design scope of projects
• Ability to lead a design workstream within a project
• Fluency in English

Preferred Requirements :

• Bachelor’s in mechanical engineering
• experienced with medical device development according to MDR or applicable FDA submission pathways
• experienced in designing injection molded plastic parts
• experienced in target costing
• experienced with Solid Works, Team Center and Polarion
• experienced in GMP, GDP
• Knowledge of German AND / OR Mandarin

We Offer

• A company culture Focusing on our Customers, Operating with Ethics and Integrity, Driving Simplicity, Learning, Improving & Delivering Together.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• Challenging assignments in a fast growing and innovative industry.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.
• Centrally located office in Zug, very close to the train station.
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