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About the role

  • Manufacturing Development Engineer scaling Arbutus Medical’s procedure-kit production from prototypes to reliable manufacturing. Bridging product development, suppliers, quality, and operations for surgical medical devices.

Responsibilities

  • Provide design-for-manufacture input early in product development.
  • Build prototypes and demonstration units for internal testing and clinician/end-user engagement.
  • Develop and execute verification and validation test methods and protocols.
  • Design and build test fixtures and apparatuses for functional, lifetime and durability testing.
  • Analyze test results and prepare technical documentation and reports.
  • Facilitate the Innovation Hub buildout, including selection, implementation and qualification of prototyping and manufacturing technologies and equipment.
  • Work with surgeons, residents, nurses and PAs to translate real-world product requirements into engineering and manufacturing solutions.
  • Partner with Quality on design controls, risk management and quality requirements.
  • Lead key elements of product transition from development into scaled manufacturing.
  • Conduct design reviews and tolerance stack-up analyses.
  • Apply GD&T to drawings, specifications and inspection requirements.
  • Design and build production jigs, fixtures and assembly tooling.
  • Develop manufacturing procedures, work instructions, assembly flow diagrams and supporting documentation.
  • Finalize technical drawings, specifications, bills of materials and exploded assemblies.
  • Establish manufacturing tolerances and inspection criteria.
  • Support first production builds and troubleshoot manufacturing issues.
  • Ensure Operations has the processes, documentation, tooling and technical knowledge needed for production.
  • Work with external manufacturers and component suppliers, including injection molders and CNC manufacturers.
  • Support supplier sourcing, technical evaluation and onboarding.
  • Review and approve first articles and pilot production batches.
  • Visit supplier facilities for mold trials, equipment setup, process development, testing and troubleshooting.
  • Develop incoming inspection and QC processes.
  • Provide technical oversight of supplier quality and manufacturing performance.
  • Investigate and resolve manufacturing non-conformances, product issues and customer complaints.
  • Lead or support product and process improvements for quality, reliability, manufacturability and cost reduction.
  • Support engineering changes and improve CAD, technical documentation and design control systems.
  • Help Operations transition new products into reliable, repeatable steady-state production.

Requirements

  • Bachelor's degree in Mechanical, Biomedical, Mechatronics, Integrated, Manufacturing or a related engineering discipline.
  • Ideally 7–10+ years of relevant engineering experience, with significant experience spanning product development and manufacturing. Candidates with less than 7 years may be considered where experience is particularly relevant and includes substantial medical device development and manufacturing responsibility.
  • Demonstrated experience taking physical products from development through manufacturing transfer and scaled production.
  • Medical device experience strongly preferred, particularly with surgical or other mechanically oriented devices.
  • Experience working within an ISO 13485, ISO 9001 or similarly regulated quality environment. Experience in another highly regulated industry such as aerospace may also be considered.
  • Strong understanding of design controls, engineering change processes, risk management and verification and validation.
  • Hands-on prototyping and product testing experience, including experience with technologies such as 3D printing, manual machining and/or CNC equipment.
  • Experience designing manufacturing fixtures, assembly tooling and test apparatuses.
  • Experience with injection molded components and working directly with injection molding suppliers.
  • Strong CAD modelling skills; SolidWorks experience strongly preferred.
  • Strong understanding of GD&T, tolerance analysis and tolerance stack-ups.
  • Experience developing drawings, specifications, manufacturing procedures and inspection criteria.
  • Demonstrated ability to work directly with suppliers to resolve manufacturing and quality issues.
  • Strong analytical and problem-solving skills, with the ability to move comfortably between hands-on troubleshooting and detailed technical analysis.
  • Excellent written communication skills and demonstrated experience preparing technical reports and engineering documentation.
  • Highly organized and comfortable managing multiple projects and priorities simultaneously.
  • Collaborative and team-oriented, with the ability to build strong working relationships across R&D, Quality, Operations and external suppliers.
  • Strong commercial awareness and an understanding of how engineering decisions affect product cost, manufacturability, customer experience and patient outcomes.
  • Ability to travel periodically to supplier locations in Canada and the United States.

Benefits

  • Competitive salary (budgeted base salary of $115,000-$125,000)
  • 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

Job title

Job type

Full Time

Experience level

SeniorLead

Salary

CA$115,000 - CA$125,000 per year

Degree requirement

Bachelor's Degree

Tech skills

Assembly

Location requirements

HybridBurnabyCanada

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