Manager, Hardware Development

Overview

Lead design, development, and manufacturing of medical device hardware while managing a team and ensuring regulatory compliance.

Key Responsibilities

• design review
• team leadership
• regulatory compliance
• ip management
• bom management
• manufacturing support

Tasks

-Oversee the evaluation of final designs to ensure requirements are met including manufacturability, safety and regulations, target cost and human factors -Facilitate the collaboration between R&D staff and colleagues from Sales & Marketing to develop an understanding of the device requirements -Manage the medical device engineering staff including recruitment, employee relations as well as learning and development -Ensure design and testing adheres to medical device or other appropriate standards (including ISO 13485, ISO 11607, ISO 11737, ISO 10993) -Contribute to the development, filing, and maintenance of the company’s intellectual property portfolio -Manage the creation and utilization of engineering documentation including Bill Of Materials (BOM) content and structure that allow for effective transfer to manufacturing under the current quality and regulatory standards -Contribute to the development and implementation of project plans including inputting on deliverables and budgets -Perform and lead others in the design and development of medical device hardware across the lifecycle including conceptualizing, designing, developing prototypes, testing, and considerations for design transfers to manufacturing -Consult with others in the organization as required to resolve development, design or manufacturing challenges or improve the efficacy of the hardware -Lead in the gathering of feedback or input and champion innovations that allow for the continuous improvement or enhancement of the company’s hardware -Facilitate medical device design and development team support to the Manufacturing Engineering team in developing, fabricating or sourcing the systems, processes, tooling and/or automation for manufacture

Requirements

• people management
• medical device
• bachelor's
• solidworks
• matlab/simulink
• six sigma

What You Bring

-Demonstrated experience and success in people management in a technical/engineering environment -Experience in a medical device design and development leadership position ideally with a systems focus -Bachelor’s or above degree in engineering (electronics or electrical) -Skilled in Design For Manufacture and ideally possessing knowledge of ultrasound and/or RF systems design to medical device standards (13485, IEC 60601) -Proficiency in MS Office (Outlook, Word, Excel, Visio, Access), SolidWorks, and Matlab/Simulink applications -Strong process development experience e.g., capability, structured problem solving (e.g., 6σ) -Proficient in project management

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Benefits

-Pay Rate: $120K - $135K Base CAD Yearly

About Raise

-Born from the 65-year legacy of Ian Martin Group, this company rethinks staffing with tech-first, self-managed operations. -Operates globally with offices in the US, Canada, Ghana, India, and the Philippines, offering permanent placement, contract recruitment, payroll/EOR, RPO, and total talent management. -Skilled trades, technical, and industry-specific teams support clients across IT, energy, manufacturing, healthcare, transportation, and more. -Tech platform uses AI-driven insights and real-time scheduling to enhance hiring speed and candidate experience. -Employs a Teal-operating, self-managed model, empowering employees to drive agility and innovation.

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