Senior Mechanical Manufacturing Engineer; Hybrid

Senior Mechanical Manufacturing Engineer (Hybrid)  Kardium Inc., 155-8518 Glenlyon Parkway, Burnaby, British Columbia, Canada

Job Description  Your opportunity  By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications.
Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – a revolutionary solution designed by our world-class technical team. The Globe System offers strong, unique, and customer-valued advantages over other treatments on the market, and leading physicians are already using it and helping to share our story.
We have obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life-changing technology to patients!
As a member of the Manufacturing Engineering team, you will be expected to have a wide breadth of knowledge of all production processes and act as the first point of contact for any feedback or problems raised by the manufacturing team. In this role, you will also be responsible for optimizing workflow of production processes in order to maximize process throughput and yield.

Having developed a keen knowledge of production processes, you will be well positioned to identify areas for process and product enhancement. You are expected to triage, design and implement process enhancement projects as well as collaborate with the design engineering team to provide DFM input and develop solutions.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of  Your responsibilities will be to:
Define,develop the business caseand implement equipment and process improvements for current and next generation products
Plan capacity,equipment and infrastructure needs as part ofimplementingnew production lines and scale up activities.

Scale up can include supportofnew manufacturing sites,outsourcing to suppliers or OEMs.
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 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 todetermineroot cause of ongoing quality issues and drive implementationofappropriate solutions
Provide input into product designs as part of the design for manufacturability process
Serve as a process subject matter expert (SME) andassistwith 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
What you bring to the team  Our Kardium team is smart, creative, and passionate about developing cutting‑edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable.
You will be successful in this role because you possess these attributes:
10+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

Experience with , and solid understanding of, statistical process controls, lean manufacturing, kaizen ix-sigma implementation is preferred
Demonstrated ability to manage multiplecomplexprojects with a high degree of accuracy and timeliness
Experience in developing manufacturing floorplan layouts…