New Product Introduction Engineer (Hybrid)

at  Kardium Inc

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 – we have a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.
We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
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 the execution of operations projects 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 includes the setup and support of transfers to the Kardium training center. This position will report to the Team Lead - NPI.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of

• Initiating Engineering Change Orders (ECO) and driving manufacturing related change control activities
• Plan capacity, equipment and infrastructure needs as part of implementing of new production lines and scale up activities. Scale up can include support of new manufacturing sites, outsourcing to suppliers or OEMs.
• Coordinating and driving process validations, process requirements and risk review activities across multi-functional teams to ensure timely process transfer to manufacturing
• Manage equipment design, fabrication and/or upgrades, qualification and implementation for production and training center equipment.
• Lead Design for Manufacture (DFM) & Design for Assembly (DFA) efforts on engineering programs and provide feedback to the design team on improvement
• Generating work instructions, production travellers and equipment IQ protocols/reports.
• Coordinating sample builds with Planning and Manufacturing as required and ensuring that any issues encountered during sample build are fed back to the design team
• Support change management of operations infrastructure software (example: PLM, ERP etc)
• 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
  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:

• Bachelor’s degree in an engineering, technical or scientific field
• 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 technical aptitude and ability to understand and communicate complex technical issues
• Strong, practical knowledge of R&D, NPI, supply chain, planning and quality control
• Effective verbal and written communication skills
• Excellent interpersonal skills and ability to drive decisions and work cross-functionally within an organization
• Proven project coordination and management skills
• Strong mechanical and electrical aptitude
• Adept with MS Office and strong ability to swiftly come up to speed with new software tools
• Able to operate independently with minimal direction
• Flexible and adaptable to take on additional responsibilities as appropriate

Compensation
Kardium has listed the total cash compensation range (base salary + 5% RRSP contribution) that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted.

As a permanent employee, you will also participate in Kardium’s stock option plan.

• $70,000 - $100,000 (CAD Annually)

Your Benefits & Well-being
Total cash – the total cash we’ve listed for this position includes a base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals.
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.
Life at Kardium
What makes us a great place to work?
1. Our Purpose
2. Our People
3. Our Culture
At Kardium, we embrace diversity of background, experience, and perspective and we’re committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.
We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Brazilian ERG and Irish ERG.
As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.
And our employees think we are great too – check out Glassdoor to learn more