Product Sustaining Engineer II

Paragon 28, Inc.•Englewood, CO

1d•$80,000 - $100,000•Onsite

About The Position

The Product Sustaining Engineer II takes a leading role on projects that support legacy product systems. These are meaningful projects that focus on supporting legacy products in the post launch life cycle with increasing levels of autonomy.

Requirements

Requires a bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline with a minimum of 3 years of experience.
Proficiency in MS Office
Effective communication and presentation skills with ability to convey information and respond to questions from groups of peers
Ability to work in a team environment

Nice To Haves

Prior experience in the sustaining or development of medical devices preferred.
Understanding of medical device industry regulatory requirements preferred.
Experience with CAD. SolidWorks preferred.

Responsibilities

Holds a leading role in the production of deliverables pertaining to sustaining engineering activities for legacy product systems, as directed by senior engineering staff including:
Review and evaluation of product non-conformances for incoming legacy product
Review and evaluation of product complaints
Post launch global registration sequences and support regulatory team according to priority.
Creation of post-launch documentation to support global registrations design control documentation for P28 design history files & technical files.
Documentation remediation efforts including: DHF documentation, risk documentation, inspection plans, protocols and reports.
Create Engineering Change Requests (ECR) and manage through completion.
Development related CAPAs; lead in root cause analysis to investigate issues.
Update designs and device specifications for legacy products
Development of testing protocols and testing process for product evaluations
Participate in activities related to project timelines for sustaining activities (i.e. Smartsheet)
Participate in activities related to project phase gate design reviews for projects requiring phase gate reviews.
Participate in discussions with 3rd party suppliers, contractors, testing houses, etc.
Inspection of current and newly developed medical devices; update inspection plans as necessary.
May mentor junior Engineers
Other duties as directed by manager