Mechanical Manufacturing Engineer (Hybrid)
Kardium Inc. is focused on developing innovative medical devices for the treatment of heart rhythm disorders. The Mechanical Manufacturing Engineer will be responsible for optimizing production processes, implementing equipment improvements, and collaborating with design engineering to enhance product manufacturability.
Responsibilities
- Define, develop the business case and implement equipment and process improvements for current and next generation products
- Plan capacity, equipment and infrastructure needs as part of implementing new production lines and scale up activities
- Plan manufacturing floor layouts for current and future product designs to maximize efficiency
- Manage equipment design, fabrication and/or upgrades, qualification and implementation for production and training center equipment
- Lead or participate in design and manufacturing process workflow reviews
- Review manufacturing process cycle time trends and process workflows and develop strategies to remove capacity bottlenecks
- Collaborate with design and quality engineering to determine root cause of ongoing quality issues and drive implementation of appropriate solutions
- Identify and communicate workstation utility requirements to facility team
- Develop and drive implementation of WIP and finished good product storage solutions
- Provide input into product designs as part of the design for manufacturability process
- Serve as a process subject matter expert (SME) and assist with identification and delivery of technician training requirements
- Provide front line support to the manufacturing team for process and equipment related issues
- Lead or participate in Lean and Kaizen events and drive continuous improvement projects
Skills
- Bachelor's degree in mechanical, bioengineer or industrial engineering
- 1-5 years' experience in design or manufacturing engineering in a regulated manufacturing environment, preferably in the biotechnology, pharmaceutical, diagnostics, or medical devices industry
- Experience with value stream mapping, design for manufacture, and change control management
- Demonstrated ability to manage multiple projects with a high degree of accuracy and timeliness
- Experience in developing manufacturing floorplan layouts based on activity relationship analysis
- Experience with, and solid understanding of, statistical process controls, lean manufacturing, kaizen/six-sigma implementation
Benefits
- Comprehensive medical & dental coverage – for all permanent employees – effective as of Day 1, with no waiting period.
- Work-day flexibility – additionally, we provide 3 personal days per year.
- Support – for you (and your dependents) overall well-being.
- Career progression and learning support.
- Professional membership support.
- Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.
Company Overview