About Us:
We are a trailblazing team revolutionizing healthcare through cutting-edge wearable medical devices. Our mission is to enhance patient care and transform healthcare delivery by combining advanced medical technologies, wearable electronics, and soft goods design. We are looking for an experienced and visionary mechanical engineer to join us on this journey of innovation and impact.

Role Overview:
We are seeking a Senior Mechanical Engineer with 10+ years of experience in mechanical design for medical devices and wearables. This role demands a proven track record of leading projects across the full product lifecyclefrom concept development to manufacturing. Prior experience with virtual reality (VR), augmented reality (AR), or related wearable technologies is highly desirable. As a key contributor to the team, you will ensure our designs meet clinical, regulatory, and user requirements, while pushing the boundaries of innovation.

Key Responsibilities:

• Lead the design and development of mechanical systems for wearable medical devices, including enclosures, housings, and integrated soft goods.
• Drive projects through the entire product lifecycle, from initial concept and feasibility studies to design, prototyping, testing, and manufacturing ramp-up.
• Ensure compliance with medical device standards (e.g., ISO 13485, IEC 60601) and regulatory requirements (e.g., FDA, MDR).
• Prior experience delivering medical devices to the US market to be used in patient homes.
• Develop innovative solutions that seamlessly integrate mechanical, electronic, and soft-good components.
• Oversee risk analysis, failure mode assessments, and verification and validation activities.
• Collaborate with multidisciplinary teams, including industrial design, software, hardware, and regulatory teams, to deliver holistic, user-focused solutions.
• Engage with manufacturing partners to optimize designs for mass production, ensuring cost-effectiveness and scalability.
• Mentor junior engineers, fostering a culture of excellence, collaboration, and continuous learning.
• Participate or lead hiring activities for mechanical engineering.
• Project management as assigned.
• Supervision or management of employees as assigned.
• Collaborate with internal and external teams to ensure mechanical designs are aligned with industrial design direction.

Qualifications:

• Bachelors degree in mechanical engineering, masters degree in mechanical engineering, biomedical engineering or optical engineering considered an asset.
• 10+ years of experience in mechanical design, with a focus on medical devices and wearable technology.
• Extensive experience leading projects across the full product lifecycle, including design for manufacturability (DFM) and design for assembly (DFA), including early-stage ideation and concept design.
• Expertise in SolidWorks.
• Deep knowledge of materials science, including biocompatible and medical-grade materials.
• Experience in integrating soft goods, flexible materials, or textiles into wearable device designs.
• Strong understanding of medical device development processes, including risk management, design controls, and usability engineering.
• Excellent leadership and communication skills, with experience driving cross-functional collaboration.

Preferred Qualifications:

• Experience with VR, AR, or related wearable technologies as part of a product portfolio.
• Proven ability to innovate at the intersection of hardware, software, and industrial design.
• Familiarity with human-centric design principles and ergonomics for wearable devices.

What We Offer:

• The opportunity to work on life-changing technology that has a direct impact on patient outcomes.
• A collaborative and supportive environment where innovation and creativity thrive.
• Competitive compensation, benefits, and career growth opportunities.
• The chance to shape the future of healthcare through pioneering wearable medical devices.

If you are a senior mechanical engineer with a passion for innovation, a proven ability to deliver products from concept to manufacturing, and expertise in wearable medical technologies, we invite you to join us and make a difference.