Platform Product Lead - Operations

About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues. 

Job Overview

Join SHL Medical’s Operations Engineering Team at our state-of-the-art manufacturing facility in Zug, Switzerland. As the technical owner you will be the driving force behind the successful commercial manufacturing of a high-impact product/platform, ensuring operational excellence, scalability, compliance, and continuous improvement. You will lead cross-functional initiatives and act as the go-to expert for technical, quality, and capacity-related matters, collaborating with senior management and key stakeholders. If you thrive in a fast-paced environment and are passionate about operational excellence and technology transfer, this is your opportunity to make an impact!

Main Responsibilities

• Cross-functional leader role interacting with senior management, various departments, internal stakeholders and clients
• Overall technical responsibility for a product/platform introduced into commercial manufacturing at the site; primary focus on operations, production and supply
• Lead SME for product, process, capacity and compliance knowledge related to a specific product/platform; Technology transfer receiver function 
• Primary contact for any complex technical issues of the product in production. RCA lead in case of complaints, NCMRs or other quality events 
• Lead the development of improvement plans and requirements for capacity expansion and future production setups for a specific product/platform 
• Lead cross-functional improvement programs and capacity deployment for your product/platform
• Establish and maintain appropriate structures to ensure communication, flow of information and documentation for the assigned product 
• Ensure effective change management and implementation of site infrastructure enabling fast and sustained ramp-up of production and benefit realization 
• Liaise with Production, Supply Chain, Quality and Development functions to deliver operational results and to ensure efficient and timely resolution of day-to-day production issues 
• Understand and influence the manufacturing control strategy for the device

Minimum Requirements

• Degree in Engineering
• At least 6 years of relevant industry experience in medical device development, engineering, and/or manufacturing
• Strong understanding of production processes and systems (e.g., injection molding, metal/spring forming, automated assembly, packaging)
• Solid knowledge of medical device regulations (ISO 13485, 21 CFR 820, cGMP, Change Control, CAPA, Design Controls)
• Experience in process and/or equipment qualification and validation
• Advanced knowledge of problem-solving and Root Cause Analysis (RCA) methodologies
• Proven project management and leadership experience in complex, multi-stakeholder projects
• Track record in leading a team of highly specialized experts
• Strong team player, self-starter, and results-driven mindset
• Ability to manage urgency and ambiguity in a fast-paced, evolving environment
• Excellent intercultural and interdisciplinary communication skills
• Fluent in English and German

Preferred Requirements

• Willingness to spend an extended period in Taiwan for initial training/induction
• Previous experience in the development and manufacture of autoinjectors or drug delivery devices
• ISO 13485 Lead Auditor certification
• Mandarin language skills (nice to have)

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. 
• Flexible hours and hybrid working policy. 

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents 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 role.