Senior Manager Medical Product Engineering

Cytiva

Newquay, United Kingdom

The Senior Manager Medical Product Engineering is responsible for management of the Pall Medical Product Engineering Team, and the delivery of product lifecycle engineering projects including product changes, VAVE, and the manufacturing transfer and validation of new products.

This position reports to the Director Medical Technology and is part of the Product Engineering Team located in Newquay and will be an on-site role.

What you will do:

Manage the prioritization and overall project execution of Product Lifecycle projects across the global Pall Medical product portfolios
Work closely with R&D, Operations, Product Management, Regulatory and Quality to introduce new products into the market, from manufacturing transfer, through validation to product launch and post launch review
Implement and sustain visual project management for the high-level plans for projects, supporting teams with identifying bottlenecks and collaborating closely with key partners to resolve scheduling issues, along with overseeing and reporting progress
Drive clear communication and reporting of critical project progress to leadership teams
Manage the performance and development of Associates within the Product Engineering Team in support of their professional development and career growth
Ensure that the Medical Product Engineering Team operates in compliance with the requirements of the relevant ISO standards ISO 9001, ISO 13485, and FDA CFR 820, and the Medical Device Regulations and their revisions.
Control departmental budget planning and monitoring of planned spending and resource allocation

Who you are:

Degree in Science or Engineering, or equivalent experience
At least 8 years’ experience of production/process engineering, ideally within the field of consumable medical devices or a similarly regulated industry
At least 3 years’ experience of leading an engineering team through product lifecycle projects
Understanding and experience of the technical change control validation techniques within the guidelines of an ISO 13485 Quality Management System
Demonstratable project leadership, data analysis and problem-solving skills
Competent in prioritizing and managing multiple projects concurrently to time, cost and quality commitments, including the assignment of resources based on business need
Experience of providing leadership, guidance, and coaching to technical team members, in support of their professional development and career growth

Travel, Motor Vehicle Record:

Ability to travel – Occasional travel, typically within UK and Europe, although opportunities exist to attend Kaizen events globally
Must have a valid driver’s license with an acceptable driving record