Device Engineer

Sentior, Ltd.; Schaffhausen; Hybrid; CHF 138.000 - 193.000; Vollzeit

Zusammenfassung

Sentior, Ltd. in Schaffhausen, Switzerland, seeks a Senior Device Engineer (m/f/d) to provide technical leadership for lifecycle engineering in a regulated pharmaceutical environment.

The role covers development, transfer to manufacturing, and ongoing production of device components for combination products, with 3 days on-site and 2 days from home. You will lead root-cause investigations, manage risk, coordinate testing and documentation, and liaise with Engineering, MSAT, Quality and

Qualifikationen

• BS in Engineering or Science; 5+ years in medical device design, development, NPI or technical support; regulatory knowledge favored.

Aufgaben

• Contribute to development and improvement of processes and qualification of systems that support combination products and their device constituents.
• Lead root-cause investigations and implement corrective and preventive actions; produce clear technical documentation and present findings to stakeholders.
• Collect, analyse, and summarize manufacturing, quality, and engineering data to support decision-making and project reporting.
• Coordinate testing activities, data collection campaigns, equipment evaluations, and implementation verification activities.
• Creation of technical, testing, investigational, and risk documentation.
• Provide device lifecycle engineering across product, process and site support for internal and external manufacturing networks.
• Drive projects to improve customer satisfaction, product quality, manufacturing efficiency, and cost reduction; contribute to manufacturing network strategy and execution.
• Combine hands-on work with meetings and risk documentation alongside local stakeholders.
• Technical problem-solving: lead root-cause investigations, implement robust corrective actions, and summarize technical outcomes in written reports and presentations.

Kenntnisse

Technical leadership

Lifecycle engineering

Data analysis

Risk assessment

Project management

Root-cause analysis

Technical writing

Communication

Cross-functional collaboration

Ausbildung

BS in Engineering or Science

Tools

Word/Excel

Document management systems

Jobbeschreibung

Senior Device Engineer (m/f/d) — Manufacturing Science & Technology (MSAT), Device Lifecycle Management (LCM)Location: Schaffhausen, Switzerland (with 3 days on-site and 2 days working from home; occasional domestic and international travel required)Language requirements: English & GermanDuration: Start date ASAP and contract running until 1st November 2027Hours: 40 hours per weekImagine your next project taking on a senior individual-contributor role to provide technical leadership for lifecycle engineering, drive process capability improvements, and support critical device projects that advance the future of human health.The Senior Device Engineer provides technical and project execution support for strategic manufacturing and device-related initiatives within a regulated pharmaceutical environment. In this role, you will provide technical leadership for lifecycle engineering and support of device components for combination products including secondary packaging across development, transfer to manufacturing, and ongoing production. You will be a key technical contact for operations and quality, drive product and process stabilization, and ensure compliance with applicable regulatory and quality requirements.This role is responsible for coordinating engineering activities, driving implementation projects, managing technical documentation, and supporting cross-functional teams to ensure timely delivery of project objectives. The position involves data analysis, risk assessment support, process improvement activities, and development of technical reports, procedures, and presentations. The Senior Device Engineer serves as a key liaison between Engineering, MSAT, Quality, Operations, and external partners, ensuring robust execution, clear documentation, and compliance with applicable quality and regulatory requirements.roles and responsibilities- Contribute to the development and improvement of processes and qualification of systems that support combination products and their device constituents.- Interpret and apply technical, regulatory and scientific documentation to inform engineering decisions and product actions.- Lead root-cause investigations and implement corrective and preventive actions; produce clear technical documentation and present findings to stakeholders.- Collect, analyse, and summarize manufacturing, quality, and engineering data to support decision-making and project reporting.- Coordinate testing activities, data collection campaigns, equipment evaluations, and implementation verification activities.- Creation of technical, testing, investigational, and risk documentation.- Provide device lifecycle engineering across product, process and site support for internal and external manufacturing networks.- Drive projects to improve customer satisfaction, product quality, manufacturing efficiency, and cost reduction; contribute to manufacturing network strategy and execution.- Combine hands-on work (observing production lines and documenting testing) with meetings and risk documentation alongside local stakeholders.- Technical problem-solving: proven ability to lead root-cause investigations, implement robust corrective actions, and summarize technical outcomes in written reports and presentations.- Decision-making: sound judgment, conflict-resolution skills and the ability to make timely, data-driven, and rational decisions.- Technical writing: Ability to create clear, accurate, and compliant technical documentation, translating complex engineering and quality information into well-structured reports, procedures, specifications, and presentations for diverse stakeholders.- Data & computer literacy: intermediate-advanced use of document management systems, Word/Excel and basic databases; able to apply statistical techniques to analyse data.- Communication & collaboration: strong verbal, written and interpersonal skills; experience working across organizational levels and in matrix environments.- Leadership & organization: manage multiple priorities and projects; coordinate with cross-functional teams.how to succeed- Degree: BS in Engineering or Science required, with a preference for Mechanical, Biomedical, or Materials.- A minimum of 5 years' relevant experience in medical device design, development, new product introduction and/or technical support. (Additional experience in combination products or manufacturing-scale projects is highly desirable.)- Languages: Fluent in spoken and written English; advanced knowledge in spoken and written German.- Strong written (reports, SOPs, procedures) and oral presentation skills for internal teams, customers, and regulatory audiences.- Regulatory, Quality & Technical Systems: Required experience with FDA regulations (CFR Parts 3, 4, 210, 211, 820) and medical device quality systems (Design Control, Change Control, CAPA, Complaint Handling).- Familiarity with ISO 13485 and European medical device regulatory requirements preferred.- Familiarity with risk and quality tools (FMEA, FMECA, etc.), engineering drawing interpretation, and process validation.- Familiarity with combination product cGMP and related regulatory requirements is advantageous.- Process improvement: experience with Six Sigma or equivalent statistical/process improvement approaches is a plus.- Project management capability and/or certification is a plus.- Physical Requirements/Working Conditions: This primarily office-based role involves desk work—sitting, walking, and routine use of phone and computer—with occasional lifting up to 30 lbs. It operates in a virtual, international team across multiple time zones using email, file sharing, conference calls and video meetings, and requires occasional domestic and international travel to J&J sites, suppliers, contractors and other partners.benefitsThis role offers a very competitive hourly rate. This contract will start ASAP and finish 1st November 2027.