Advantage Technical · 20 hours ago
Research And Development Engineer
Twin Cities Area
Contract
Hybrid
Senior Level
$69/hr - $69/hr
5+ years expAdvantage Technical is seeking an R&D Engineer who will independently conduct development work as part of major research and new product development projects. The role involves significant contributions to the design and development of a new large-bore delivery catheter and associated regulatory deliverables.
Staffing & Recruiting
No H1B
Hiring Manager
Bill Sunderland
Responsibilities
Collaborate with a small team of new product design engineers on the development of a new large-bore delivery catheter
Independently develop key deliverables required for a 510(k) regulatory submission, including:
CAD designs
Detailed print packages
Specification generation and rationale
Mapping specifications to essential design outputs
DFMEAs
Tolerance analyses
Device material assessments
Bill of materials
Provide guidance to product and technology teams
Assess feasibility and soundness of alternative engineering processes, products, or equipment
Coach others on engineering documentation and best practices
Demonstrate strong PDP/TPD system knowledge through high-quality, high-impact deliverables
Coordinate, manage, and document project goals and progress
Recommend revisions to project plans as needed
Work effectively in a mixed onsite + remote environment
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline
5+ years of experience in design assurance, new product development, or related medical device/regulated industry roles
Strong experience with design controls, print packages, tolerance analysis, and GD&T
Demonstrated ability to create detailed technical documentation
Self‑motivated with strong problem‑solving skills and a bias for action
Excellent verbal and written communication skills
Demonstrated use of quality tools and methodologies
Preferred
Experience with medical devices such as catheters or delivery systems
Quality Integration experience
510(k) regulatory experience
Understanding of ISO 13485, ISO 14971, and Quality System Regulations, especially Design Controls and Risk Analysis
Strong problem‑solving skills and ability to facilitate structured problem‑solving processes
Experience with design changes, complaint reduction, and corrective actions
Adaptable collaborator in both team‑based and self‑directed work environments
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase