Senior Device Engineer – Medical Device and Combination products

Senior Device Engineer – Medical Device and Combination products

Senior Device Engineer – Medical Device and Combination products

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Direct message the job poster from Beyond Conception GmbH

Talent Acquisition Manager - Life Science & Pharmaceuticals for Consultys - Beyond Conception - AM Group - AL Group - All are a VULCAIN ENGINEERING…

As a Senior Device Engineer specializing in medical devices and combination products, you will support clients in developing and optimizing device components, ensuring that products meet performance, regulatory, and quality standards. You will work on a diverse range of projects, contributing technical expertise to device design, testing, and lifecycle management.

Key Responsibilities:

• Device Design and Development: Collaborate with R&D teams to design and develop device components for medical devices, and combination products, creating clear and comprehensive product requirements and specifications, ensuring they meet user needs and regulatory requirements..
• Design Control Compliance: Lead design control activities in accordance with ISO 13485, 21 CFR Part 820 and EU MDR,, ensuring thorough documentation throughout the design and development phases.
• Technical Specifications and Risk Management: Define product specifications, conduct risk assessments, and contribute to design failure mode effects analysis (dFMEA) to proactively address potential risks and improve device safety and performance.
• Verification Testing: Plan, execute, and document verification activities, including bench testing, and device shelf-life studies, to ensure products meet performance, safety and efficacy criteria .
• Support for Regulatory Submissions: Prepare and review technical documentation for regulatory submissions, supporting clients in achieving approval in key markets (e.g., FDA 510(k), PMA, CE marking).
• Cross-Functional Collaboration: Work closely with regulatory, quality, manufacturing, and clinical teams to ensure that device design aligns with overall project goals and regulatory requirements.
• Supplier collaboration: work with third party suppliers to ensure their output meets project and QMS requirements.
• Product Lifecycle Management: Provide engineering support for lifecycle management of existing products, including post-market modifications, continuous improvement efforts, and support for complaint investigations.
• Compliance and Standards Adherence: Stay updated on relevant standards and industry best practices, including ISO 10993 (biocompatibility), ISO 11608 (needle-based devices), ISO 14971 (risk management), and IEC 62366 (usability engineering), as applicable to medical devices and combination products.
• Client Communication and Reporting: Regularly update clients on project progress, prepare technical reports, and ensure transparent and effective communication of technical findings and recommendations.

Profile:

You are a meticulous and technically proficient device engineer with a strong background in the development and testing of medical devices and combination products. You thrive in a dynamic environment and have a passion for ensuring that products meet the highest standards of safety and performance.

You possess:

• 10+ years of experience in device engineering, manufacturing and assembly processes, focusing on medical devices or combination products.
• Expertise in creating and reviewing Intellectual Property (IP), creating, managing and maintaining CAD models, technical drawings and Tolerance Analysis.
• Expertise in developing mechanical designs and technical solutions, applying design controls, risk management, and V&V processes for regulated products.
• Knowledge of relevant regulatory frameworks and standards, including ISO 13485, 21 CFR Part 820 and EU MDR, and other applicable standards.
• Strong problem-solving and analytical skills, with experience in root cause analysis and failure investigations.
• Excellent communication and documentation skills, with a detail-oriented approach to technical reporting.
• A university degree in engineering, biomedical engineering, or a related field.
• Fluency in English is required; additional language skills, such as French or German, are a plus.

You may also have:

• Experience with device engineering specific to combination products, such as prefilled syringes, autoinjectors, or inhalers.
• Familiarity with statistical methods for data analysis and experience with software for V&V testing and documentation.
• Knowledge of quality systems and the ability to apply continuous improvement principles within a regulated environment.

What You Can Expect:

• A collaborative environment with access to a diverse portfolio of projects in medical devices and combination products.
• Opportunities for professional growth and development, including specialized training and access to industry conferences.
• A supportive team dedicated to high-quality engineering and continuous improvement.
• Flexible working arrangements, including hybrid/remote work options and normal working hours.
• A competitive salary commensurate with your experience and location.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting

• Industries

  Medical Equipment Manufacturing

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