Senior Micro-Mechanical Engineer – Medical Device

KEY SKILLS AND TEMPERAMENT:

• Real talent for micro-mechanical design,
• Passionate about enhancing performance and reliability of innovative micromechanical medical system to delights users.
• Committed to finding the best design for manufacturing solutions to keep COGS low.
• Committed to finding the best technical solutions to enable the best possible user experience.
• Keenly accountable to deliver on-time, on-budget work product that exceeds expectations.

· Strong at making right technical decisions especially in short-deadline and fast-paced planning context.

• Autonomous and proactive, with a team player mindset.

 

PRIMARY DUTIES & RESPONSIBILITIES:

• Reliability development of innovative, highly integrated micro-mechanical systems and sub-systems, including force and movement transmission modeling and calculating.
• Dimensioning and tolerancing calculations.
• Testing and improvement of these micro-mechanical systems and sub-systems in order to reach product specifications.
• Optimize and finalize the micro-mechanical systems design, ensuring its safety, performance and manufacturability.
• Define the micro-mechanical systems specifications and associated testing plan.
• Write parts specifications and draw plans.

· Participate in micro-mechanical systems risk analysis (both design and process FMEAs).

• Imagine, define, and implement micro-mechanical systems production and testing processes.
• Creation of assembly and test instructions.
• Participate in the validation of the manufacturing processes in order to obtain FDA clearance (Medical Device GMP).
• Management of sub-projects including material and parts supplying and stock management
• Partner closely with other team members to successfully bring prototypes in clinical study.
• Independently manage third-party vendors.
• The employee may be required to perform other tasks for the smooth running of the company.

REQUIRED QUALIFICATIONS:

1. Knowledge, skills & abilities:

• Good knowledge in production techniques and automation.
• Advanced knowledge of Solidworks, use of surfaces an asset.
• Good knowledge of plastic injection molding.
• Knowledge in medical manufacturing validation, GMP an asset.
• Good knowledge of various micro-mechanical production techniques.
• Excellent knowledge of micro-mechanical assembly tolerancing.
• Knowledge of micro-motor technology is an asset
• Fluent in English and French preferred, German an asset.
• Demonstrated ability to work in a fast-paced start-up environment in a small team setting.
• Knowledge of laser welding, an asset
• Strong organizational and time management skills.
• Excellent team-player, very good ability to work independently.
• Good communication and presentation skills.
• Ability to take initiative, learn quickly, be enthusiastic and curious.

 

1. Minimum certifications/educational level:

• Master's degree in microengineering, or equivalent.

 

1. Minimum experience:

• 8 years of professional experience.
• Experience deploying medical device or automotive development projects from pre-series to market approval.
• Experience in the development of a Class II or III electromechanical medical device. Including experience with development within an ISO 13485 certified eQMS, or similar.
• Experience in writing requirements and technical specifications.
• Experience with measuring systems, fluid measurement, an asset.
• Experience with FDA validation of medical devices, a plus.