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R&D Engineer II
2 months ago
R&D Engineer II (12-month contract // Hybrid - Plymouth, MN):
Candidate is expected to be on site 3 days per week
Top Required Skills:
- R&D Experience in medical devices and the quality/regulatory processes around them, preferably for on-market/sustaining products
- Experience developing regulatory strategy/updates, especially related to EU MDR compliance
- TM development & TMV execution
- Experience working with internal and external manufacturing
Education Required: Bachelor’s Degree in Engineering or similar discipline
Target Years of Experience: 2-5 years
Description:
This role is within our client’s Peripheral Vascular Health organization’s Released Product Management R&D team. The team covers a portfolio of devices that includes self-expanding stent, balloon expanding stents, drug and non-drug coated balloons, embolic protection, atherectomy, procedural support, chronic total occlusion, among others to treat the Peripheral Arterial Disease state. The team is responsible for sustaining released products and ensuring patient safety and quality requirements are continually met. This includes addressing changing regulatory requirements, working through internal and external manufacturing changes, conducting accelerated and real time aging, as well as the protocol/documentation associated with all the activities.
Primary Responsibilities:
- Coordinating with the quality and regulatory teams to develop test plans and change implementation plans.
- Interacting with suppliers and internal manufacturing sites to work through non-conformances and changes.
- Planning Test Method development and TMVs.
Must Have Skills:
- Experience developing regulatory strategy/updates, especially related to EU MDR compliance
- TM development & TMV execution
- Investigation and root cause analysis skills
- Technical writing knowledge
- Process validation knowledge
- Ability to work with department peers and middle-management within the marketing, engineering, and manufacturing functional groups.
Preferred Skills:
- Experience in PVH products (Stents, Balloons, catheters, procedural support) would be beneficial.
- Experience working with internal and external manufacturing sites.
- Experience with sustaining released product
