Manufacturing Development Engineer - Arbutus Medical

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 looking for an experienced, hands-on Manufacturing Development Engineer to bridge the gap between product development and scaled manufacturing.

What We Offer

• 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

About the Role

This is a broad, high-impact role for an engineer who enjoys getting deeply involved in how products are designed, built, tested and ultimately manufactured. You will work alongside R&D from the early stages of product development, helping build prototypes and clinician demos, designing test methods and fixtures, and ensuring designs can be reliably manufactured at the required quality and cost.

As products move toward commercialization, you will take a leading role in the transition to manufacturing. Working directly with suppliers, developing manufacturing and inspection processes, supporting first articles and pilot builds, troubleshooting production issues, and ensuring product requirements translate successfully into real-world manufacturing.

Unlike a traditional "throw it over the fence" transfer model, you will remain closely involved after launch, helping Operations and suppliers stabilize production, resolve manufacturing challenges and continuously improve product quality and manufacturability.

This is an ideal opportunity for a technically strong engineer who loves to build things, break things, solve problems and see their work translate directly into products used in patient care.

Key Responsibilities

Product Development, Prototyping & Testing

• Get involved early in product development to provide design-for-manufacture input.
• Build prototypes and demonstration units for internal testing and engagement with clinicians and other end users.
• Develop and execute test methods and protocols supporting verification and validation (V&V) activities.
• Design and build test fixtures and apparatuses for functional, lifetime and durability testing.
• Analyze test results and prepare clear technical documentation and reports.
• Facilitate buildout of our Innovation Hub with selection, implementation and qualification of prototyping and manufacturing technologies and equipment, including 3D printers and other fabrication tools.
• Work directly with surgeons, residents, nurses, and PAs to understand real-world product requirements and translate them into practical engineering and manufacturing solutions.
• Partner with Quality to ensure appropriate design controls, risk management and quality requirements are incorporated throughout development.

Manufacturing Development & Transfer

• Own key elements of the transition from product development into manufacturing, ensuring designs can be consistently and reliably produced at scale.
• Conduct design reviews and tolerance stack-up analyses to identify potential manufacturing risks before production.
• Apply GD&T principles to drawings, specifications and inspection requirements.
• Design and build jigs, fixtures and assembly tooling required for production.
• Develop manufacturing procedures, work instructions, assembly flow diagrams and supporting documentation to ensure repeatable manufacturing at high quality.
• Finalize technical drawings, specifications, bills of materials and exploded assemblies for manufacturing.
• Establish appropriate manufacturing tolerances and inspection criteria that balance product requirements with real-world manufacturing capability.
• Support first production builds and troubleshoot issues as products move from development into steady-state manufacturing.
• Ensure Operations has the processes, documentation, tooling and technical knowledge required to successfully manufacture new products at high quality.

Supplier & Manufacturing Engineering

• Work directly with external manufacturers and component suppliers, including injection molders, CNC manufacturers and other specialized vendors.
• Support the sourcing, technical evaluation and onboarding of new suppliers and manufacturing partners.
• Ensure suppliers understand and can consistently achieve product specifications, tolerances, quality standards and inspection requirements.
• Review and approve first articles and pilot production batches against technical specifications.
• Visit supplier facilities as required to support mold trials, equipment setup, process development, testing and troubleshooting.
• Identify opportunities to modify tooling, equipment, processes or designs to improve manufacturability, quality and consistency, then execute required changes
• Develop appropriate incoming inspection and QC processes for new components and assemblies.
• Analyze, verify and validate supplier processes where required.
• Provide ongoing technical oversight of supplier quality and manufacturing performance as products scale.
• Partner with suppliers to investigate issues and implement corrective or preventative improvements.

Sustaining Engineering & Continuous Improvement

• As the technical specification expert, remain actively involved with products after launch to support manufacturing stability and continuous improvement.
• Investigate and resolve manufacturing non-conformances, product issues and customer complaints in partnership with Quality and Operations.
• Troubleshoot issues identified during early and ongoing production builds and determine appropriate design or process changes.
• Lead or support product and process improvements focused on quality, reliability, manufacturability and cost reduction.
• Evaluate whether existing specifications and inspection requirements remain appropriate, achievable and consistently met by manufacturing partners.
• Support engineering changes and ensure they are appropriately evaluated, documented, verified and implemented.
• Improve CAD, technical documentation and design control systems and practices.
• 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.