PDAP - (Senior) Assembly Process Engineer

About SHL Medical

SHL Medical is the 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 Unites States.

Job Overview

As a Senior Assembly Process Engineer in Assembly Process Development team, you will play a crucial role in defining the assembly strategy, from early drug delivery system concept, to when a fully automated assembly line is handed over to operations.

You will work in a cross-functional team including but not limited to drug delivery system designers, component manufacturing experts, automation engineers and quality representatives. Key responsibilities include Design for Assembly, lab tests, designing pilot lines, defining requirements for commercial assembly lines, support technical reviews and commissioning.

Main Responsibilities

Design for Assembly:

• Review of drug delivery system for manufacturability (Design for Assembly)
• Provide improvement possibilities, including novel redesigns of drug delivery system
• Ensure parts are fit for automatic feeding (e.g. vibration blow)
• Ensure final product can efficiently be transported (e.g. integrity and orientation can be kept in trays)
• Ensure drug delivery system performance requirements are achievable and possible to control
• Collaborate with simulation department and vendors to derisk the drug delivery system (assembly perspective)
• Negotiate cross-functional tradeoffs to find compromise between design, component manufacturing and assembly

Process Development:

• Identify failure modes, critical process parameters and critical material attributes
• Define and document test plan
• Design fixtures and methods to reproduce critical steps of the assembly process
• Execute tests, analyze data and document results
• Define process windows and requirements

Pilot line Development:

• Develop efficient concepts for pilot assembly line (e.g. Flexible Robot Assembly line)
• Design product specific fixtures (e.g. Work Piece Carriers and Gripper Fingers)
• Document design per GAMP5 to build complete Design Qualification package
• Establish work instructions and SOPs
• Commission pilot line and support PLC/Robotics engineer
• Support Validation engineer in establishing qualification protocols and reports

Commercial line Development:

• Provide product specific requirements to establish equipment specifications
• Provide product specific expertise in equipment design reviews and challenge proposed solutions
• Support commissioning and qualification activates
• Support root cause investigation activities, including executing lab tests.

Qualifications

1. Educational Background and Experience:

• Bachelor’s or master’s degree in Automation, Mechanical Engineering, or a related field
• At least 3+ years of experience in automation environment and or in mechanical design related function

2. Technical Skills:

• Proficiency in using CAD software and other engineering design tools
• Ability to create technical drawings (GD&T) and do Tolerance Analysis

3. Soft Skills:

• Strong problem-solving and analytical abilities.
• Excellent communication and teamwork skills for collaboration across disciplines.
• Proactive, self-motivated, and eager to learn new tools and technologies.

4. Desirable Experience:

• Previous involvement in automation systems, process development, or industrial software development is a plus.
• Knowledge of automation technologies, robotics (Fanuc), and control systems (TwinCAT) is a plus

Language Skills

• Must have : Fluent in English - Strong intercultural and interdisciplinary communication skills

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.

For more information on SHL Medical, please visit: shl-medical.com/careers

Please note: We do not accept applications from recruitment agencies for this position.