Process Engineer-Device Engineering New

Company Profile:

The site prides itself on being on the forefront of cutting‑edge R&D and delivering high quality products while focusing on niche therapeutic areas. If interested simply apply below or if you'd like more information reach out to myself for a confidential conversation today.

Key Responsibilities:

• Design and develop robust, high-yield manufacturing processes to ensure consistent and reliable product quality.
• Optimize equipment and process technologies to enable the successful scale-up and transfer of efficient, dependable processes into full production.
• Collaborate with GDE teams to facilitate the design, validation, and seamless transition of new medical devices from development through to manufacturing.
• Manage and support external vendors in the design, fabrication, and installation of manufacturing equipment—from concept development through factory integration.
• Drive continuous improvement and innovation across existing equipment and processes to support New Product Introductions (NPIs).
• Prepare, maintain, and update comprehensive process and manufacturing documentation.
• Author and execute validation and qualification protocols (IQ/OQ/PQ) for manufacturing equipment and processes.
• Lead process improvement initiatives to uphold the highest standards of quality, efficiency, and compliance.
• Collaborate cross-functionally to support both current production and future manufacturing requirements.
• Act as a site-level subject matter expert in specific manufacturing technologies and contribute to knowledge sharing and team development.
• Oversee the commissioning and scale-up of new manufacturing technologies, with particular focus on microcatheter production.
• Conduct risk assessments in collaboration with Environmental Health & Safety (EHS) teams when introducing new equipment, materials, or chemicals, ensuring minimal environmental impact.

Essential Requirements:

• Strong technical or engineering background in new product development and sustaining engineering within the medical device industry.
• In-depth understanding of medical device regulations, including FDA 21 CFR Parts 801 and 820, design controls, ISO 13485, regulatory audits, and international environmental standards. Proven experience in developing 510(k)/PMA-regulated products is required.
• Bachelor’s degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, or related disciplines).
• Minimum of 5 years’ experience in the medical device sector.
• Exceptional analytical and problem-solving skills.
• Strong interpersonal and negotiation abilities, with the capacity to reconcile differing viewpoints while advancing business objectives.
• Excellent written and verbal communication skills, with proficiency in MS Office and project management tools.

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