Senior Process Engineer

We are looking for a skilled and motivated Senior Process Engineer to join our team and play a key role in the development and implementation of high-performance manufacturing solutions for medical devices. Working closely with R&D and Manufacturing, this role will focus on scaling innovative technologies from concept through to production, ensuring efficiency, reliability, and quality at every stage.

Key Responsibilities:

• Design and implement robust, scalable manufacturing processes that deliver high yield and consistent product quality.
• Develop and optimize equipment and process technologies to support seamless transfer into high-volume manufacturing.
• Collaborate with R&D to guide new product designs through the development lifecycle into full production readiness.
• Partner with external vendors to design, build, and integrate manufacturing equipment from concept to factory deployment.
• Drive process innovation and continuous improvement to support New Product Introductions (NPIs).
• Create and maintain comprehensive process and manufacturing documentation.
• Develop and execute equipment and process validation protocols (IQ, OQ, PQ).
• Lead initiatives focused on enhancing process reliability, product quality, and operational efficiency.
• Work cross-functionally to support current operations and prepare for future manufacturing demands.
• Serve as a subject matter expert on specific manufacturing technologies, supporting team knowledge development.
• Oversee the introduction and scale-up of advanced manufacturing technologies, particularly for microcatheter production.
• Collaborate with Environmental Health & Safety (EHS) teams to assess and mitigate risks related to new equipment, materials, or chemicals.

Qualifications & Experience:

• Bachelor's degree (Level 8) in Engineering or a related scientific field (e.g., Mechanical, Manufacturing, Electronic, or Production Engineering).
• Minimum of 6 years of relevant experience in the medical device industry.
• Strong communication and interpersonal skills, with a proven ability to lead and influence.
• Demonstrated problem-solving skills and a strong analytical mindset.