New Product Introduction (Npi) Engineer

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 minimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other heart-related complications.

Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

Kardium has a unique opportunity for an experienced New Product Introduction (NPI) Engineer. As a member of the Manufacturing Engineering team, the NPI Engineer will be responsible for smooth transfer of new or updated product designs and processes into production and for ensuring that changes are implemented in a coordinated and organized manner that meets project timelines. This position will report to the Manufacturing Engineering Manager.

What You’ll Be Doing

Your responsibilities will include:

• Coordinating and driving process validations, process requirements and risk review activities across multi-functional teams to ensure timely process transfer to manufacturing
• Initiating Engineering Change Orders (ECO) and driving manufacturing related change control activities
• Plan capacity, equipment and infrastructure needs as part of implementing new production lines.
• Lead Design for Manufacture (DFM) & Design for Assembly (DFA) efforts on engineering programs and provide feedback to the design team on improvement
• Ensuring that any issues encountered during sample build are fed back to the design team
• Maintaining technology transfer progress dashboards and providing updates on a periodic basis
• Continuously identifying opportunities to improve the efficiency of the technology transfer process to manufacturing
• Generating work instructions, production travellers and equipment IQ protocols.
• Coordinating sample builds with Planning and Manufacturing for all Process Validation (PV) activities and ensuring input part designs and build instructions are available

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 are suited to our approach and possess these attributes:

• Proven project coordination and management skills
• Flexible and adaptable to take on additional responsibilities as appropriate
• Strong technical aptitude and ability to understand and communicate complex technical issues
• Effective verbal and written communication skills
• Adept with MS Office and strong ability to swiftly come up to speed with new software tools
• Excellent interpersonal skills and ability to drive decisions and work cross-functionally within an organization
• Bachelor’s degree in an engineering, technical or scientific field
• Strong, practical knowledge of R&D, NPI, supply chain, planning and quality control
• Minimum 3 years’ experience in a technology transfer, manufacturing operations or engineering change management role in a regulated manufacturing environment, preferably in the biotechnology, pharmaceutical, diagnostics, or medical devices industry
• Strong mechanical and electrical aptitude
• Able to operate independently with minimal direction

Why work at Kardium

A meaningful career working with a truly innovative technology and an ambitious team, combined with:

• An engaged leadership team who believes in mentoring and growing employees’ careers
• Supportive and fun colleagues with plenty of social events to encourage people connections
• Opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and clinical and regulatory affairs
• A great working environment with opportunities to develop your skills and knowledge
• Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide
• And our employees think we are great too – check out Glassdoor to learn more!

Thanks in advance for your interest in Kardium!