Skills Looking For:

• Responsible for design change; Experience with Cardiovascular medical devices.
• T he primary role will be design control. Working on two major projects and 4 smaller projects; All aspects of Design control and Risk management.
• Mechanical e engineering degree will be given first preference. Will also consider bio-medical degree. No other degrees will be considered.
• 5+ yrs of med device implantable device experience is needed.
• Familiarity with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
• Development Quality or R&D Engineering experience is fine.
• Supply quality engineer or manufacturing quality experience WILL NOT BE A GOOD FIT. Do not submit such candidates.
• Develop test methods, test method validations, documenting results and writing reports, writing protocols and ensuring they are followed.
• Test method validation skills.
• Some statistical knowledge, Minitab exp preferred.
• Strong communication skills required.

Education and Level of Experience:

• Mechanical engineering degree is required. Only flexible for bio-med engineering degrees. No other degrees will be acceptable.
• 5+ years of medical device experience.

Top S kills:

• Design Controls knowledge; when there is a change to the product, able to access what needs to be tested and what protocol needs to be created.
• Development quality/design quality exp.