RM - Senior Risk Management Engineer

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

As a Senior Quality Engineer with a focus on risk management, you will bridge the gap between quality engineering and business analysis, ensuring our PLM systems, risk management processes, and regulatory workflows align with business needs.

You will collaborate with cross-functional teams, translate quality and medical device risk management principles into system workflows to implement and maintain quality systems throughout the product lifecycle, and contribute to continuously improving product development and compliance processes.

Furthermore, the successful candidate will collaborate with customers and internal stakeholders to apply regulatory and engineering knowledge to develop Risk Management Files (RMFs) for devices designed and manufactured by the company in accordance with relevant standards such as ISO 13485, ISO 14971, ISO 11608.

Main Responsibilities

• Liaise Quality, IT, and Engineering teams, translating regulatory and business needs into system workflows and PLM applications.
• Analyze and document quality, risk, and design control business processes, ensuring compliant implementation in enterprise PLM tools.
• Collaborate with enterprise teams to optimize and integrate quality and regulatory processes into product development and manufacturing workflows.
• Apply software development methodologies, including requirements specification, use case development, user stories with testable acceptance criteria, and test case development and execution.
• Act as a solution-focused team player, contributing to cross-functional device and application projects.
• Lead medical device lifecycle risk management and reliability engineering activities, adhering to standards like ISO 14971, ISO 11608, IEC 60812, IEC 61025, and IEC 62403.
• Participate in project intake activities to assess feasibility of project proposals from a risk management perspective.
• Collaborate effectively with customer representatives throughout the product lifecycle, including establishing and reviewing medical harms and hazard assessments that adhere to SHL requirements.
• Assist the project team in conducting risk management activities to ensure device risk management file effectiveness and compliance.
• As Risk Manager, establish, review, and approve documents and records, and participate in design reviews. Participate in internal and external regulatory audits, including third-party audits of product risk management and design history files. Implement and administer the SHL Risk Management process, including Corrective and Preventive Actions and Change Controls. Stay informed about regulatory and compliance changes.

Minimum Qualifications

• Master of Science degree in scientific or life science engineering discipline with 2 years of work experience (preferred), or University-level education with 3-5+ years of relevant experience working in medical device compliance, design quality assurance, quality engineering, business analysis, or a related field.
• Evidence of training completion (required) or certification (preferred) in Quality System Regulation, Medical Device Quality Management Systems, and Application of Risk Management to Medical Devices.
• In-depth knowledge of quality systems requirements, design controls, quality assurance & statistics, risk management, reliability engineering, and good documentation practices.
• Demonstrable hands-on experience in drug-delivery system design, development, manufacturing or post-market support according to QSR or MDR.
• Familiarity with software development processes, and proven expertise in business analysis, requirements and test management, and translating regulatory needs into enterprise workflows.
• Excellent documentation, presentation, and interpersonal communication skills via all methods in a cross-functional, international and multicultural environment, i.e., in-person, and by phone, email, teleconference and video conference are essential for this role.
• Strong analytical and problem-solving skills, with the ability to work effectively with data and enterprise systems, including PLM tools.
• Ability to work in a fast-paced, cross-functional environment and manage divergent stakeholder expectations.

Language

• Must have: English
• Nice to have: Mandarin

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.