R&D Engineer :::: Arden Hills,Minnesota

Key Responsibilities
1. Work with a small team of new product design engineers focused on the design of a new large bore delivery catheter
2. Works independently to develop key deliverables as part of a 510k regulatory submission. Deliverables include, but not limited to: CAD design, detailed print packages, specification generation and rationale, specification mapping to essential design outputs, DFMEAs, tolerance analysis, device material assessment(s), and bill of materials.
3. Provides guidance to product and technology teams.
4. Assesses the feasibility and soundness of alternative engineering processes, products, or equipment.
5. Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
6. Develop and coach others on engineering documentation.
7. Demonstrates PDP/TPD system knowledge through coaching and delivery of high quality, high impact deliverables.

REQUIREMENTS:
Minimum of a bachelor's degree in mechanical or biomedical engineering (or other related technical discipline)
5+ years of experience in design assurance, new product development or related medical device / regulated industry experience
Experienced in design controls, print packages, tolerance analysis, GD&T
Self-motivated with a passion for solving problems and a bias for action
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
Ability to effectively work and collaborate in a mixed onsite + remote environment
Demonstrated experience creating detailed technical documents

Preferred qualifications:
Experience working with medical devices such as catheter or delivery systems
Quality Integration experience
510k regulatory experience
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Experienced problem solver, capable of facilitating the problem-solving process
Adaptable and effective collaborator in a team environment or in self-directed work
Experience with design changes, complaint reduction, and corrective action.