Product Development Engineering Manager
Opera is a family owned business passionate about enhancing lives, built on values of care, support, passion and professionalism. Established in 2004 Opera has become a market leader in designing and producing care beds and pressure care mattress systems for the long term care market. We are an expanding business and really keen to grow our team with people who naturally reflect and can live our values.
At present we have an exciting opportunity for a product development engineering manager to oversee the design and development of new and innovative care and adjustable beds, mattresses and related medical devices. You will bring projects from concept/ design stage through to regulatory approvals and onto sale.
In this role you will work closely with our quality and compliance manager to ensure design and testing compliance with the required standards and Medical Devices Regulation (MDR).You will be responsible to:
Relevant qualifications and experience required for this role includes:
- Facilitate the concept and design of products that meet the project's needs
- Working closely with the stake holders to gather relevant concept information and define outcomes
- Engage relevant vendors and subcontractors to support the needs of the project
- Provide project leadership that includes management of budget, timeline and resources.
- Generation of project documentation in line with ISO13485 and other medical device regulatory requirements
- Attend and organise regular project meetings and generation of regular project update reports to the Board
- Develop product test methods, data analysis and evaluations to determine or prove product performance and reliability alongside the quality manager
- Function within all quality systems and regulations, particularly related to medical devices and ensure appropriate documentation
- Degree in mechanical engineering
- Medical device product development (class 1) (3 years plus)
- Product approval with regulatory compliance
- Experience of working with ISO13485
- Experience of managing multiple projects consecutively
- Managing and motivating a small team
The role will be based at the Opera head offices in Hull, HU7 3AP with working hours 8:00am-4:30pm.
If you have the skills and can demonstrate similar values we'd love to hear from you.