Noze Looking for Senior Project Manager, Medical Devices at Canada Full Time

Noze has digitized the sense of smell. We’ve done for the nose what the camera did for the eyes and the microphone did for the ears. It took six years and some help from NASA, but we did it. Now it’s time for us to bring it to the world.

People who succeed at Noze have a sense of urgency, a ton of initiative, infinite curiosity, a strong internal drive, and an enthusiasm for bleeding-edge tech. If you’re bursting with fresh ideas and want to join a company in its journey to change the status quo, then this opportunity is for you!

Who you are:

You are a creative, detail-oriented, and hands-on system level thinker with an aptitude for technology and a passion for translating scientific knowledge into products that help to save lives. You have experience developing new medical devices through a design control process from concept to commercialization and the tenacity to drive projects to completion on time and on budget.

You will be a part of a multidisciplinary team of engineers and scientists where you’ll play a central role in the development and evaluation of devices that would integrate mechanical device design, chemo-receptors, advanced sensing materials, IOT architecture, and Artificial Intelligence. If you enjoy overseeing multiple product development and technology evaluation projects, then this could be the place where you can utilize your experience to have a direct impact on the growth and development of our products.

What you will do:

• Lead and manage projects from early development through the Design Control process in compliance with ISO 13485.

• Ensure design control activities such as risk management, design verification/validation, and design reviews are effectively carried out and documented.

• Manage the creation and upkeep of Design History Files (DHF) for medical devices in accordance with QMS and regulatory requirements, including design requirements, technical specifications, verification and validation test reports, and risk assessment documentation.

• Coordinate and manage internal product evaluation studies, ensuring participants are trained, devices are distributed and in working order, and all data and results are accurately recorded and analyzed.

• Coordinate with cross-functional teams, including device, software, AI, sensor, and data annotation teams and external vendors for effective execution of projects, ensuring they are delivered on time, within scope, and within budget.

• Develop comprehensive project plans, track project performance, and report project progress to senior management.

• Manage relationships with stakeholders, and act as a central point of contact for project-related communications.

• Perform risk management to minimize project uncertainties.

What you need:

• Bachelor’s degree in Engineering, Science, or a related field. Advanced degrees and/or Project Management Professional (PMP) certification are a plus.

• Minimum of 5 years of experience in product development and/or project management in the medical device industry, under an ISO 13485 and/or FDA CFR QMS.

• Extensive knowledge of Design History File (DHF) compilation, management, and maintenance.

• Demonstrated experience in conducting and managing product evaluation studies.

• Experience performing risk assessments using methods such as failure modes and effects analysis (FMEA) would be considered an asset.

• Excellent interpersonal, written, and verbal communication skills.

• Proven ability to manage complex projects and multifunctional teams.

• Strong working knowledge of project management software (e.g., MS Project, Asana, etc.).

• Exceptional attention to detail and organizational skills.

• Proven problem-solving skills, hands-on approach to work, and “get it done” mentality.

• Ability to function in a fast-paced start-up environment and ability to adjust workload based upon changing priorities.

What we offer:

• The opportunity to join a forward-thinking company surrounded by a collaborative team of innovative thinkers

• A rewarding career path with diverse opportunities for professional growth

• A competitive compensation and benefits package including employer paid health and dental benefits for regular, full-time employees

• A generous learning and development budget to attend conferences, classes, and other events

• A bunch of other perks that involve food, fun, and travel