Company Profile:

Our long-standing client a leading medical device company are seeking an experienced Process Engineer to join their global device engineering team on an initial 12-month contract. The company possess a significant manufacturing and R&D presence that's been maintained via astute and robust capital investment. 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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