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.
