Newly developed leadership role within an exciting and niche market.
Lead a design team to improve design and enhance products.
Be a part of a passionate and collaborative culture.
About the company
With over 30 years experience in research and design, Cyclopharm brings an innovative and niche radio-pharmaceutical product to the healthcare industry. Cyclopharm are driven by enhancing and developing medical innovations for diagnostic imaging, specialising in lung health. This is an exciting time to join the organisation as they embark on obtaining new market share and enhancements of their products.
About the opportunity
In this role, you will be responsible for reviewing and improving the entire product life-cycle within a highly regulated environment.
You will lead a team, the design of new products as well as existing product re-design, write engineering documents that meet quality and regulation requirements, create user requirements and functional documentation, manage the verification, validation and design transfer process as well as develop engineering SOP's and best practise.
Duties
Management of manufacturing engineering department.
Writing of engineering documentation and procedures.
Investigating issues related to manufacturing, production or design.
Risk analysis and validation in accordance to quality and regulation requirements.
Design, develop and improve on processes.
Budget management.
Project management.
Ensure deign and development of products from planning through to control stages are inline with MDSAP requirements.
Work closely with quality and regulations teams to ensure product compliance.
Encourage design opportunities and develop proposals.
Investigate and justify R&D grant opportunities.
Skills and Experience
Tertiary qualification in Engineering is essential.
Experience working within the medical device industry is essential with solid knowledge on Quality & Regulations.
Experience in design engineering within the medical device industry is required.
Ability to design, develop and improve on engineering processes.
Background in R&D and manufacturing is ideal.
Excellent communicator with the ability to influence.
Hand's on with excellent problem solving skills and ability to write detailed engineering documentation.
Strong knowledge of the industry, regulations, codes and guidelines is essential.
Strategic with good business and financial acumen.
Collaborative and able to work in an environment with consistent change.
Culture
Innovative minds, collaborative and close-knit.
How to Apply
Click apply or contact Michelle Vermaak on 02 8877 8760 for a confidential discussion.
