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 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
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