Manager, Process Improvement Design Controls & PLM

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 Manager of Process Improvement Design Controls & PLM is a key leader responsible for driving process excellence in the development of SHL’s drug delivery medical devices.
This role focuses on improving QMS and business processes related to product development with design controls and managing the Product Lifecycle Management (PLM) tools. The manager will lead a cross-functional team of process analysts, process specialists, PLM tool owners and system architects to drive forward SHL’s digitalization journey, end-to-end process harmonization, and foster continuous improvement of our product development processes while ensure compliance with regulatory requirements (FDA, ISO 13485). By enhancing design controls, optimizing PLM usage, and driving digital transformation, the role supports the company's commitment to innovation, quality, and patient safety.

Main responsibilities

1. Leadership & Team Management

• Build, manage, and mentor a cross-functional team of process improvement analysts and specialists and PLM owners and system architects.
• Set clear team objectives, monitor progress, and provide feedback to ensure continuous development and high performance.
• Promote a culture of continuous improvement, collaboration, and accountability within the organization.
• Serve as a strategic partner to R&D, Quality, and Manufacturing teams to ensure alignment on key design control and PLM initiatives.

2. Business Process Improvement (Design Controls for Medical Devices)

• Lead efforts to improve, standardize, document and digitalize design control processes for autoinjector development, ensuring compliance with FDA 21 CFR Part 820 and ISO 13485.
• Identify inefficiencies and bottlenecks in the design control process and implement effective solutions.
• Lead the development of tools, templates, and systems that streamline the design control process for product development.

3. PLM Ownership (Teamcenter & Polarion Operation & Optimization)

• Own the configuration, maintenance, and optimization of the PLM system, ensuring alignment with internal business needs and regulatory compliance.
• Collaborate with Innovation, Product Development, Process Development, Quality, and Operations to identify system gaps, manage system upgrades, and enhance user functionality.
• Align PLM investments and efforts to the SHL and CTO strategy.
• Define, monitor and improve PLM performance metrics.
• Provide training, guidance, and support to end-users and stakeholders to ensure effective use of Teamcenter and Polarion.

4. Regulatory Compliance & Audit Readiness

• Ensure design control processes comply with FDA QSR, ISO 13485, and ISO 14971 for autoinjector medical device development.
• Collaborate with Regulatory Affairs, Quality Assurance, and Design Engineering to ensure regulatory compliance during internal and external audits.
• Facilitate internal process audits, identify gaps, and develop corrective and preventive action plans (CAPAs) as needed.

5. Continuous Improvement & Change Management

• Drive process digitization, automation, and system integration to improve operational efficiency in product development.
• Manage the introduction of new process changes in design controls and oversee change management strategies, training plans, and impact assessments.
• Act as a change champion to drive digital transformation for design controls processes.

Minimum Requirements

• Bachelor’s or Master’s degree in Engineering, Quality, Business Administration, or a related technical field.
• 7+ years of experience in the medical device industry with a focus on design control processes and regulatory compliance.
• 3+ years of experience in a leadership or management role, with proven experience leading cross-functional teams.
• Design Controls: Expert knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 risk management for medical devices. Familiarity with design history files (DHF), design reviews, verification/validation (V&V), and risk management processes.
• Change Management: Experience leading digital transformation initiatives, including stakeholder engagement, training, and adoption strategies.
• Fluency in English

Preferred Requirements

• PLM Systems: In-depth understanding of PLM tools like Teamcenter, including configuration, administration, and optimization for medical device DHF, DMR, and DHR management.
• Direct experience with autoinjector, combination products, or other Class II/III medical devices is highly preferred.
• Leadership: Ability to inspire, coach, and develop teams to achieve results.
• Problem Solving: Analytical mindset with a data-driven approach to identifying root causes and corrective actions.
• Communication: Strong verbal, written, and presentation skills to influence stakeholders at all levels of the organization.
• Collaboration: Ability to work cross-functionally with R&D, Manufacturing, Regulatory, and Quality teams.

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 position.