Our partner is an exciting start-up technology that uses neuromodulation to fix a challenging problem that improves patient outcomes and creates significant cost savings to the industry, as well. Currently, the company is selling its product internationally and is close to getting FDA approval, which will lead to adding the right talent to the US team. It is a great leadership team with extensive industry experience, successfully bringing positive products to the market. SSI is supporting multiple critical roles as they grow their US Team, including a Lead Quality Engineer position. This important position will support design quality activities, dFMEA, and supplier quality interactions.

The Right Talent:

BS in Engineering, Science, Lifesciences, or a relevant degree

7+ Years of relevant experience supporting Class II & III medical devices

Experience with Design Inputs/Outputs and DHF

Experience with Design Verification & Validation, Quality for Design, and Design remediation

Experience with ISO 14971 & 13485

Strong experience collaborating with R&D, RA, Operations, & Manufacturing to ensure product quality

Experience supporting audits, product reliability, and product safety

Experience with auditing, SCAR, and supporting supplier score cards

Permanent and Remote Opportunity