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Mechanical Testing Team Lead

2 weeks ago

Burnaby, British Columbia, Canada Kardium Inc. Full time

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

The main focus of mechanical testing team lead is to ensure mechanical testing resources can objectively verify and test Kardium's products and designs. Testing of high-complexity medical devices is an important component of Kardium's product development process and is required to ensure product quality and competitiveness. The breadth and comprehensiveness of the testing that is required and expected for a revolutionary device such as the Globe is significant.

Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.

Meaningful work you will be a part of

Your responsibilities will include:

Planning and execution of all mechanical design verification and process validation activities

  • Plan scope of mechanical testing, ensuring coverage of essential requirements, external standards, and effectiveness of risk mitigations.
  • Participate in design requirement and specification reviews to ensure that requirements and specifications can be validated and verified.
  • Assess and plan ECO, change-control-related, and other QMS-related verification activities related to mechanical design or process changes.
  • Drive mechanical design verification reviews.
  • Ensure adequate test articles are available for testing, including planning type and quantity, requesting sample production, assisting sample release, and organizing required preconditioning.
  • Prioritize, schedule, track and conduct mechanical V&V activities in coordination with stakeholders.
  • Drive generation and maintenance of V&V documentation including TPs, TRs, design verification reviews, detailed test and sample planning and tracking documents, traceability upkeep and matrices, as well as high-level planning documents and high-level reports to support regulatory submissions.
  • Manage initiation, tracking, and resolution of issues investigations and CAPAs related to the results of mechanical verification and validation activities.
  • Coordinate with other team leads and specification document owners to ensure that conclusions of test reports and design review reports are adequately acted upon.

Development and maintenance of a company‐wide support infrastructure for testing

  • Test equipment, jigs and fixtures:

Identify and document requirements.

Drive design (where applicable), procurement, and implementation, as well as commissioning and qualification.

Ensure all equipment used in testing is calibrated and maintained as required.

  • Build in-house knowledge on sampling plans, statistics relating to test result analysis, and experimental design and provide DoE support to all groups within Kardium.
  • Identify, document, and validate Standard Test Methods and Test Method Validations.
  • Coordinate with Engineering TLs to set up and manage mechanical testing lab space.
  • Maintain the mechanical-V&V-related SOPs, plans, and procedures.
  • Improve the documentation and organization of mechanical V&V activities to enable better scaling and test result tracking.
  • Ensure test personnel training and domain knowledge is up to date, current, and state of the art.

Team Leadership

  • Ensure adequate staffing level for mechanical V&V activities based on work scope and required areas and levels of expertise.
  • Provide constant feedback to team members and conduct performance and compensation reviews.
  • Provide mentorship to junior team members.
  • Work with team members to identify and address training needs.
  • Create vision for Testing Team to that meets the challenge of supporting commercials products at scale concurrent with ongoing engineering development activities

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 of Science or Engineering degree.
  • Minimum of 5 years of experience in design or test engineering.
  • Multidisciplinary understanding of the Globe system.
  • Solid communication and documentation skills.
  • Flexible and adaptable to take on additional responsibilities as appropriate.
  • Familiarity with international standards and FDA guidance documents related to medical devices, especially as they relate to V&V e.g. ISO 14971, IEC 60601, ISO 10555, CFR 21 Part 820.
  • Strong organizational, leadership, and management skills.

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.

  • $105,000 - $120,000 (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