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
The Business Process Manager Hardware Verification & Design for Manufacturing (DFM) plays a key role in driving process excellence across development of drug delivery devices, with a strong focus on Product Verification and DFM practices. This position ensures that processes are designed, implemented and continuously improved to enhance product quality, compliance and manufacturability.
As a strategic enabler within the technical organization, the role supports our mission to manage, develop and optimize end-to-end development processes. Working with teams in R&D, Quality, Regulatory, Manufacturing Engineering and Operations, the Business Process Manager will ensure that processes within the technical organization support business objectives and operational excellence. Based in Zug, this role will collaborate closely with other process managers and cross-functional teams to ensure effective and efficient workflows.
Ultimately, the Business Process Manager Hardware Verification & DFM ensures that robust, efficient and compliant processes enable faster innovation, seamless collaboration and sustainable product development across SHL.
Main Responsibilities
-
Design, implement and continuously improve end-to-end business processes related to Design Verification, DFM and associated domains (Hardware Design, Risk Management, Testing, Manufacturing Readiness).
-
Ensure compliance with regulatory and quality standards throughout the product lifecycle, including medical device regulations.
-
Collaborate with R&D, Quality, Regulatory, Manufacturing Engineering, Operations, and IT to harmonize processes, documentation, and align with production requirements.
-
Develop and maintain process documentation (Work Instructions, Templates, Guidelines) and training materials ensuring compliance with medical standards and company QMS.
- Conduct workshops, training sessions and stakeholder interviews to identify process gaps, drive adoption and support change management initiatives.
-
Translate business needs into functional solutions and work with system architects to implement and validate PLM solutions.
-
Monitor process performance, report KPIs, and collect user feedback to drive continuous improvement.
Minimum Qualifications
-
7+ years of relevant experience and success in process management within the medical device or pharmaceutical industry.
-
Strong knowledge of mechanical design , hardware verification processes, Design Controls and DFM principles.
-
Excellent strategic thinking, problem-solving and analytical capabilities with a focus on continuous improvement and innovation.
-
Ability to influence and communicate effectively across all organizational levels, promoting transparency and collaboration.
-
Ability to work in a fast-paced, global environment with multiple priorities.
-
Bachelor’s or Master’s degree in Engineering, Quality Management, Industrial Engineering or related field.
-
Fluency in English is required.
Preferred Qualifications
-
Familiarity with PLM systems and digital documentation workflows (e.g. Signavio).
-
Experience applying agile methodologies in process design.
-
Certification in Lean Six Sigma, Process Management or Project Management (e.g. PMI, IPMA) is a plus.
-
Training in DFM methodologies and Verification standards preferred.
-
Experience with ISO 13485, FDA regulations, or similar compliance frameworks.
-
German skills are a plus.
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 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.
