Senior Manufacturing Equipment Design Engineer
LIVANOVA is a global medical device company and a leader in the treatment of cardiovascular diseases. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, Our Burnaby Plant focuses on one main therapeutic area and that is the production of bioprosthetic heart valves for heart valve replacement surgery.
The successful candidate will be responsible for leading engineering activities associated with the design, troubleshooting and validation of manufacturing equipment used to process and sterilize heart valve products. In addition, the successful candidate will implement operational initiatives that enhance efficiency and compliance of manufacturing and engineering operations:
- Provide engineering services to the manufacturing plant including detailed drawings for the development and manufacturing of prototype systems, such as: rotating equipment, pressure vessels, hydraulic design for piping systems, modular pumps and chemical processing systems
- Engineer and implement highly capable & effective manufacturing processes
- Work with the manufacturing equipment maintenance department on designing and troubleshooting manufacturing equipment Collaborate with Process and Quality Engineering teams in developing new or modifying existing processes, providing primary DFM analysis and guidance
- Experience with DFMA and Lean development of tooling and equipment including equipment concept selection, specification, procurement and acceptance.
- Lead continuous improvement projects to enhance yield and performance of equipment and processes.
- Work with multi-functional teams to identify and resolve production / engineering issues
- Create equipment specifications to procure and integrate systems that will deliver highly capable processes, cost effective lean tooling and equipment that enable cost savings
- Planand execute process and equipment validations.
- Process development and validation from concept to production including knowledge and use of FMEA, TMV, Software Validation, IQ, OQ, PQ.
- Working hands on - on the manufacturing floor to facilitate the setup and assembly of machines and to ensure the achievement of high yield productivity.
- Working hand on – able to perform basic machining operations to produce simple prototypes of tooling and components (such as with a CNC, milling machine, or 3D printer.)
- Provide hands on support with other departments to ensure the solutions for product assembly meet organization objectives for metrics such as product cost, labor time, yield, lead time.
- Bachelors or Masters Degree in relevant Engineering discipline (Mechanical, Biomedical or Chemical Engineering)
- Minimum 10 years relevant experience in a team based regulated manufacturing environment, and ideally 2+ years’ experience at a senior level.
- Preference for a working knowledge of process control ideally by PLC and LabView
- Registered or eligible for registration as a professional engineer with Engineers & Geoscientists BC
- Experience in ProE is desirable
- Background experience in successful project completion, product introduction and transfer of prototypes design into production
- Background in Medical Device, Pharmaceutical, or Chemical Sterilization Processing is preferred
- Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
- Demonstrable analytical & problem solving skills
- Demonstrable Project Management skills.
- Strong leadership skills, a confident and effective decision maker
- Excellent written / verbal communication and presentation skills
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