Microfluidics Design Biomedical Engineer

Medical Device Development Engineer needed for an Eastern Ontario company. You will be designing and providing state of the art medical devices for their clients.

You will be playing a leading role in the design, development, prototyping, testing, and troubleshooting of the company's main device platform, used in their unique biotherapeutic processes.

Position reports to Director level.

This role is focused on product development and sustainability, not manufacturing.

Company is growing rapidly, so lots of room for upward mobility. Relo offered across Canada.

ROLE AND RESPONSIBILITIES :

• Design updates.
• Root cause analysis of complaints about product.
• CAPA, and related documentation.
• Adherence to ISO13485 or 9001 QMS.
• Work with clients re implementation of changes.
• Design sustainability for manufacture and distribution.
• Use of xFMEA technology to ID and address potential problems before they happen.

REQUIREMENTS :

• B.Eng. or M.Eng. - biomedical, mechanical, or systems.
• Strong preference for 7 to 10 years working in the medical device industry (pure academia will not suffice).
• Background in CAPA, DFM, DFA, within a regulated industry (ISO 13485 or 9001).
• Must have injection molding, fluidics, disposables background.
• Experience working with clients to implement change.
• DFM, DFA.
• CAD Solidworks.
• Love of engineering and desire to make a huge impact on health care.
• Willing to relocate to Eastern ON (at company's expense).
• Excellent oral and spoken English.
• This is an on-site, teamwork type role.
Il y a 7 jours