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Start Date:    ASAP
Type:                Full Time, Permanent
Location:      On-site role based in Vancouver

Summary

Arbutus Medical is a rapidly growing medical device venture developing a portfolio of procedure kits to  streamline surgery “outside the OR”, starting with orthopaedic trauma procedures in the ER.

We are a growing 16-person team seeking an Assembler I to support the hands-on production of our FDA-cleared medical devices, helping ensure that every product we ship meets the highest standards of quality, safety, and reliability.

What We Offer

  • Commitment to being a living wage employer (budgeted base salary of $54,500) 
  • An exciting opportunity to get in at the ground floor of a growing venture
  • Extended health benefits
  • Professional development funding
  • A purpose-driven workplace with passionate teammates who want to help patients and make a positive difference in the world

Detailed Role Description

As an Assembler I, you are a core member of Arbutus Medical’s production team, responsible for assembling and preparing medical procedure kits that are used directly in patient care. Your work ensures that surgeons, nurses, and emergency room staff receive reliable and precisely built products that help them deliver better care faster.

You will spend most of your time assembling components using hand tools, following written work instructions, and verifying that every part meets strict quality and fit specifications. You will also be trained to work within Arbutus’ quality system, documenting your work and ensuring all production records are accurate and complete. You will report to the Production Supervisor and work closely with a small, highly engaged production team that values accuracy, accountability, and continuous improvement.

Success in this role means becoming a dependable, detail-oriented assembler who can independently build products to specification, maintain clean and organized workspaces, and contribute ideas that improve safety, efficiency, and product quality over time.

Key responsibilities:

Production & Assembly

  • Assemble complex components using hand tools, following written work instructions and standard operating procedures
  • Verify component fit, alignment, and function to ensure assemblies meet all specifications
  • Maintain a high attention to detail to ensure all finished products meet quality and safety requirements
  • Follow cleanroom and sterile-handling procedures to maintain product cleanliness and readiness for sterile packaging
  • Keep the production area clean, organized, and properly labelled

Quality System & Documentation

  • Complete all required quality training for assembly and production activities
  • Locate and follow the correct work instructions, specifications, and quality documents within the quality system
  • Accurately document production activities on quality records and checklists
  • Maintain up-to-date, complete, and compliant production documentation

Continuous Improvement & Team Support

  • Identify opportunities to improve processes, ergonomics, tools, and product designs
  • Raise improvement ideas through the proper channels rather than making undocumented changes
  • Support other teams when needed to meet company goals

Requirements

  • 1–2 years of experience in an assembly, manufacturing, or hands-on technical role
  • Completion of a technical, trades, or applied-skills program (or equivalent hands-on experience)
  • Strong mechanical aptitude and manual dexterity
  • Ability to read, understand, and follow written instructions and procedures in English
  • Comfort working with tools and performing repetitive, detail-oriented tasks
  • Ability to work in a clean, controlled production environment

Desired Capabilities and Traits

  • Hands-on and mechanically curious: You enjoy building, fixing, and understanding how things fit together.
  • Detail-oriented: You notice alignment, fit, and small defects that could impact quality.
  • Process-driven: You respect documentation, repeatability, and quality systems.
  • Team-oriented: You value camaraderie, shared accountability, and helping others succeed.
  • Proud of meaningful work: You are motivated by knowing your work directly supports patient care.

Why this role, and why now?

Arbutus Medical is reinventing how surgery is done Outside the OR™,  starting within the ER, where surgeons struggle with 1M+ bedside procedures a year due to outdated workflows. We’re building the market’s first portfolio of procedure kit “grab bags” to streamline these procedures, and have launched two FDA-cleared products to date, TrakPak® (to streamline bedside skeletal traction) and SwiftKit™ (to streamline treatment of fingertip trauma). These are two truly differentiated products that solve practical workflow problems, saving up to 45 min/patient, helping hospitals win back resources and keep staff happy, while improving quality of patient care. We are already in 75+ U.S. hospitals (including more than 20% of all Level 1 Trauma Centers), have a high double-digit growth rate, and are backed by a deep roster of Canadian healthtech investors. Entering 2026, we are ready to accelerate product development and scale up US sales and medical education to set a new standard of care in our target procedures.

 

Our Commitment to Diversity, Equity, and Inclusion

Arbutus Medical is committed to making diversity, equity, and inclusion part of everything we do, from how we build our products to how we build our workforce. If this resonates with you, please apply – even if you don’t feel like you “check all the boxes.” Also, let us know if we can provide any specific accessibility considerations throughout the interview and candidate screening process.

About Arbutus Medical Inc.

Arbutus Medical Inc. is a privately held ISO13485 medical device company headquartered in Vancouver, Canada. Arbutus Medical is a medical device innovation engine that streamlines surgical inefficiencies for the good of patient care. The company is currently focused on improving the standard of care for simple orthopaedic trauma procedures commonly performed in hospital Emergency Rooms (ERs). Its two leading products are TrakPak®, a procedure kit that streamlines bedside skeletal traction, and Digit Revision SwiftKit™, a procedure kit that streamlines revision amputations of fingers and toes. In addition, the company has made one of its patented platforms, (DrillCover Technology™, which adapts DEWALT® drills for surgery) available at accessible price points around the globe. The company’s products have regulatory clearances from the U.S. Food & Drug Administration (FDA) and Health Canada, and have been used by customers in 40 countries, enabling an estimated 130,000 surgeries to date. For more information about Arbutus Medical, follow the company on LinkedIn.

We’d love to hear from you! Please apply by submitting your application through our online portal!  

Start Date: ASAP
Type: Full Time
Location: Burnaby, BC (Hybrid – 3 days onsite)

Summary

Arbutus Medical is a rapidly growing medical device venture developing a portfolio of procedure kits to streamline surgery “outside the OR”, starting with orthopaedic trauma procedures in the ER.

As we scale, we are strengthening our Quality function to support growth, ensure compliance, and enable efficient product development and commercialization.

We are seeking a hands-on Quality Assurance Lead to own and scale our Quality Management System (QMS) while supporting a critical period of operational growth.

This role will play a key leadership role in:

  • Relocating our facility from Vancouver to Burnaby
  • Preparing for and completing our ISO 13485 Surveillance Audit
  • Strengthening quality systems, audit readiness, and regulatory compliance

As the first hire with sole QA responsibility, this high-impact, high-visibility role will play a key role in structuring our systems for growth. This role is well-suited for someone who can execute while thinking at a systems level. This is a hybrid role with 3 days a week on-site at our new Burnaby facility.

What We Offer

  • Competitive salary (budgeted base salary of $90,000-120,000, depending on experience)
  • An exciting opportunity to get in at the ground floor of a growing venture
  • Flexible working hours and hybrid arrangements
  • Extended health benefits
  • Professional development funding
  • A purpose-driven workplace with passionate teammates who want to help patients and make a positive difference in the world

Key Responsibilities:

Own & Scale the Quality Management System (QMS)

  • Maintain and continuously improve an ISO 13485 / MDSAP-compliant QMS
  • Apply a pragmatic approach: ensuring compliance without unnecessary complexity
  • Ensure audit readiness across:
    • Document control
    • Training systems and records
    • Equipment and process controls
    • Supplier quality
    • CAPA and complaint handling
  • Identify system gaps and implement scalable, practical solutions
  • Conduct CAPA trend analysis and report insights to leadership
  • Ensure all quality records are accurate, complete, and audit-ready

Facility Transition

  • Ensure QMS compliance throughout the facility relocation to Burnaby
  • Update documentation, risk assessments, and processes tied to the new site
  • Partner cross-functionally with Operations to minimize disruption
  • Support validation and readiness of the new facility

Audit & Compliance Leadership

  • Lead preparation for the ISO 13485 surveillance audit
  • Act as the primary QA contact during internal and external audits
  • Strengthen audit readiness (e.g., training documentation, system gaps, UDI compliance)
  • Set and track annual quality objectives with senior leadership
  • Present KPIs, trends, and quality insights across the organization

Product & Design Quality

  • Support Design Controls (requirements, risk management)
  • Develop and implement test strategies and validation plans
  • Partner with Engineering to balance speed, compliance, and practicality
  • Lead Quality Reviews with Operations and Engineering to drive continuous improvement

Supplier & Manufacturing Quality

  • Partner with Supply Chain on supplier qualification, monitoring, and performance
  • Ensure quality consistency across sterile kits and components
  • Lead CAPAs and complaint investigations:
    • Root cause analysis
    • Corrective actions
    • Timely closure
  • Support new supplier approvals (including regulatory requirements)

Requirements

  • 5–10+ years in Quality Assurance within medical devices or manufacturing environment
    • (ISO 13485 environment or equivalent)
  • Strong working knowledge of:
    • ISO 13485 or equivalent
    • FDA 21/CFR 820
  • Proven experience with:
    • Audits (internal & external)
    • CAPA systems
    • Supplier quality
    • QMS ownership
  • Background in a technical field (engineering, science, or equivalent)
  • Strong communication skills (including customer-facing quality discussions)
  • Ability to operate in a fast-paced, scaling environment

Nice-to-Have

  • Experience with MDSAP and/or FDA regulatory requirements
  • Background with Class I/II devices, sterile products, or orthopaedics
  • ISO 13485 or ISO 9001 Lead Auditor certification
  • Experience supporting U.S. regulatory operations (e.g., UDI submissions)
  • Experience supporting or leading facility changes, audits, or scaling environments
  • Experience with internationally recognized standards for medical device development (e.g., ISO10993, ISO14971, IEC 60601, ISO 11135, ISO 11137)

Desired Capabilities and Traits

  • Hands-on operator: You execute while thinking strategically
  • Pragmatic problem solver: You know what’s required vs. what’s unnecessary
  • Detail-oriented: You ensure systems hold up under audit scrutiny
  • Cross-functional partner: You build trust across Engineering, Ops, and Supply Chain
  • Balanced mindset: You protect quality without slowing the business

Why this role, and why now?

Arbutus Medical is reinventing how surgery is done Outside the OR™, starting within the ER, where surgeons struggle with 1M+ bedside procedures a year due to outdated workflows. We’re building the market’s first portfolio of procedure kit “grab bags” to streamline these procedures, and have launched two FDA-cleared products to date, TrakPak® (to streamline bedside skeletal traction) and SwiftKit™ (to streamline treatment of fingertip trauma). These are two truly differentiated products that solve practical workflow problems, saving up to 45 min/patient, helping hospitals win back resources and keep staff happy, while improving quality of patient care. We are already in 75+ U.S. hospitals (including more than 20% of all Level 1 Trauma Centers), have a high double-digit growth rate, and are backed by a deep roster of Canadian healthtech investors. Entering 2026, we are ready to accelerate product development and scale up US sales and medical education to set a new standard of care in our target procedures.

Our Commitment to Diversity, Equity, and Inclusion

Arbutus Medical is committed to making diversity, equity, and inclusion part of everything we do, from how we build our products to how we build our workforce. If this resonates with you, please apply – even if you don’t feel like you “check all the boxes.” Also, let us know if we can provide any specific accessibility considerations throughout the interview and candidate screening process.

About Arbutus Medical Inc.

Arbutus Medical Inc. is a privately held ISO13485 medical device company headquartered in Vancouver, Canada. Arbutus Medical is a medical device innovation engine that streamlines surgical inefficiencies for the good of patient care. The company is currently focused on improving the standard of care for simple orthopaedic trauma procedures commonly performed in hospital Emergency Rooms (ERs). Its two leading products are TrakPak®, a procedure kit that streamlines bedside skeletal traction, and Digit Revision SwiftKit™, a procedure kit that streamlines revision amputations of fingers and toes. In addition, the company has made one of its patented platforms, (DrillCover Technology™, which adapts DEWALT® drills for surgery) available at accessible price points around the globe. The company’s products have regulatory clearances from the U.S. Food & Drug Administration (FDA) and Health Canada, and have been used by customers in 40 countries, enabling an estimated 130,000 surgeries to date. For more information about Arbutus Medical, follow the company on LinkedIn.

We’d love to hear from you! Please apply by submitting your application through our online portal.

Start Date:       ASAP
Type:                Full Time
Location:         Vancouver, BC (Hybrid)

Summary

Arbutus Medical is a rapidly growing medical device venture developing a portfolio of procedure kits to  streamline surgery “outside the OR”, starting with orthopaedic trauma procedures in the ER.

We are a fast growing team seeking a Product Support Designer who will be the driving force behind the continuous improvement of our existing product portfolio. Sitting at the intersection of customers, Product Development, Marketing, and Operations, you will transform real-world feedback into meaningful product improvements that strengthen surgeon preference and maximize product-market fit.

What We Offer

  • Competitive salary (budgeted base salary of $95K-110) 
  • An exciting opportunity to get in at the ground floor of a growing venture
  • Flexible working hours and work-from-home arrangements
  • Extended health benefits
  • Professional development funding
  • A purpose-driven workplace with passionate teammates who want to help patients and make a positive difference in the world

Detailed Role Description

This is a highly collaborative, hands-on role for someone who enjoys solving problems, managing multiple product improvement initiatives, and building strong relationships with healthcare providers. You’ll investigate product feedback, develop and evaluate prototypes, coordinate testing, and partner closely with our Product Development team to bring improvements through implementation and manufacturing.

Success in this role comes from being equally comfortable speaking with surgeons in a trauma centre, observing procedures, evaluating technical solutions, coordinating prototype development, and communicating progress across internal teams. You’ll manage a portfolio of continuous improvement projects, ensuring customer feedback is translated into practical product enhancements that deliver real value. If you’re naturally curious, thrive on momentum, and believe there is always a better solution, this role offers the opportunity to make an immediate impact on products that are used every day to improve patient care.

Key responsibilities:

Customer Engagement & Product Management

  • Build trusted relationships with surgeons, residents, nurses, and healthcare providers to understand how our products are used in real clinical environments.
  • Serve as the primary point of contact for customer product feedback, ensuring issues are acknowledged, investigated, and followed through to resolution.
  • Visit hospitals, cadaver labs, conferences, and customer sites to observe procedures and identify opportunities to improve product performance and workflow.
  • Maintain regular communication with customers on active product improvement initiatives, demonstrating progress and reinforcing our commitment to continuous improvement.
  • Support resident training programs and educational labs, particularly during the annual summer resident turnover period.
  • Partner with the commercial team during customer visits and regional meetings to gather insights, strengthen relationships, and support product adoption.
  • Evaluate prototypes and product enhancements in the field, gathering structured customer feedback before broader implementation.

Continuous Product Improvement

  • Own a portfolio of product improvement initiatives across our existing product line.
  • Investigate customer feedback, complaints, and enhancement opportunities to identify practical product improvements.
  • Translate customer needs into clear technical requirements and actionable development projects.
  • Lead multiple product improvement projects simultaneously, balancing priorities while maintaining momentum.
  • Identify opportunities to improve product usability, simplify workflows, increase product utilization, and reduce cost of goods (COGS).
  • Drive continuous improvement initiatives from concept through implementation, collaborating with Product Development to bring validated solutions into production.

Prototyping, Testing & Technical Evaluation

  • Develop prototypes using internal resources, 3D printing, machining partners, or other rapid prototyping methods.
  • Design and execute product testing to evaluate new concepts and product improvements.
  • Develop test protocols, fixtures, and evaluation methods to validate product performance.
  • Analyze results, document findings, and present recommendations to internal stakeholders.
  • Support investigation of product complaints by identifying root causes and recommending technical solutions.
  • Collaborate with Product Development to transition validated concepts into manufacturable product changes.

Cross-Functional Collaboration

  • Partner closely with Product Development, Marketing, Operations, Manufacturing, and Sales throughout the product improvement process.
  • Support Key Opinion Leader (KOL) initiatives by providing technical expertise and coordinating product evaluations.
  • Collaborate with Marketing to develop educational materials, product messaging, demonstrations, and technical content highlighting product improvements.
  • Build and maintain anatomically realistic product demonstrations and tradeshow displays.
  • Support technical initiatives such as product recycling programs, inspection processes, and other operational improvement projects.
  • Maintain visibility into active projects through dashboards, reporting, and regular communication with internal stakeholders.

Requirements 

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Design, Product Design, or a related technical discipline.
  • 5–7 years of experience in product development, sustaining engineering, product support, R&D, medical devices, or a related technical product role.
  • Demonstrated experience translating customer feedback into successful product improvements.
  • Experience managing multiple technical projects simultaneously from concept through implementation.
  • Hands-on experience with prototyping methods such as 3D printing, machining, CAD (SolidWorks strongly preferred), or other rapid development tools.
  • Experience creating detailed how-to guides and illustrations (Adobe Illustrator experience is an asset)
  • Experience designing, executing, and documenting product testing and validation activities.
  • Strong technical problem-solving skills with the ability to balance customer needs, technical feasibility, and business priorities.
  • Excellent communication and interpersonal skills with confidence engaging both technical and non-technical audiences.
  • Strong organizational skills with exceptional attention to detail and follow-through.
  • Willingness to travel throughout North America approximately one trip per month, with increased travel during the summer resident training season.

Preferred Qualifications

  • Experience within the medical device, surgical, orthopaedic, or healthcare industry.
  • Experience working in regulated environments (e.g. ISO 13485, FDA, Health Canada).
  • Experience observing clinical procedures or working directly with healthcare professionals.
  • Familiarity with design controls, risk management, and product change processes.
  • Experience supporting product launches, sustaining engineering, or continuous improvement initiatives.
  • Knowledge of manufacturing processes such as injection molding, machining, or medical device assembly.
  • Experience developing technical training materials, product demonstrations, or customer education content.

Desired Capabilities and Traits

  • You are relentlessly curious and genuinely enjoy understanding how customers use products in the real world.
  • You thrive on solving practical problems and turning ideas into tangible improvements.
  • You naturally build credibility and trust with customers and colleagues alike.
  • You enjoy balancing technical work with relationship building.
  • You are highly organized and comfortable managing multiple projects at different stages simultaneously.
  • You bring energy, urgency, and follow-through to every initiative, ensuring nothing falls through the cracks.
  • You believe that even great products can always be made better.

Why this role, and why now?

Arbutus Medical is reinventing how surgery is done Outside the OR™, starting within the ER, where surgeons struggle with 1M+ bedside procedures a year due to outdated workflows. We’re building the market’s first portfolio of procedure kit “grab bags” to streamline these procedures, and have launched two FDA-cleared products to date, TrakPak® (to streamline bedside skeletal traction) and SwiftKit™ (to streamline treatment of fingertip trauma). These are two truly differentiated products that solve practical workflow problems, saving up to 45 min/patient, helping hospitals win back resources and keep staff happy, while improving quality of patient care. We are already in 75+ U.S. hospitals (including more than 20% of all Level 1 Trauma Centers), have a high double-digit growth rate, and are backed by a deep roster of Canadian healthtech investors. Entering 2026, we are ready to accelerate product development and scale up US sales and medical education to set a new standard of care in our target procedures.

Our commitment to Diversity, Equity, and Inclusion

Arbutus Medical is committed to making diversity, equity, and inclusion part of everything we do, from how we build our products to how we build our workforce. If this resonates with you, please apply – even if you don’t feel like you “check all the boxes.” Also, let us know if we can provide any specific accessibility considerations throughout the interview and candidate screening process.

Competitive Salary

Our salary budgets are designed using comprehensive market data and to reflect the range of skills and experience we need for the position and allow room for growth. For experienced individuals we typical hire at the mid-point of the band. The top portion is reserved for employees who demonstrate sustained high performance and impact at Arbutus. Those who are new to the role may join below the mid-point and develop their skills overtime. The final offer amount for this role will depend on applicable skill set of the candidate.

About Arbutus Medical Inc.

Arbutus Medical Inc. is a privately held ISO13485 medical device company headquartered in Vancouver, Canada. Arbutus Medical is a medical device innovation engine that streamlines surgical inefficiencies for the good of patient care. The company is currently focused on improving the standard of care for simple orthopaedic trauma procedures commonly performed in hospital Emergency Rooms (ERs). Its two leading products are TrakPak®, a procedure kit that streamlines bedside skeletal traction, and Digit Revision SwiftKit™, a procedure kit that streamlines revision amputations of fingers and toes. In addition, the company has made one of its patented platforms, (DrillCover Technology™, which adapts DEWALT® drills for surgery) available at accessible price points around the globe. The company’s products have regulatory clearances from the U.S. Food & Drug Administration (FDA) and Health Canada, and have been used by customers in 40 countries, enabling an estimated 130,000 surgeries to date. For more information about Arbutus Medical, visit arbutusmedical.com and follow the company on LinkedIn.

We’d love to hear from you! Please apply by submitting your application through our online portal!