Advantage Technical · 19 hours ago
Research And Development Engineer
Twin Cities Area
Contract
Onsite
Senior Level
$69/hr - $69/hr
5+ years expAdvantage Technical is a company focused on research and development within a highly regulated medical device environment. The Senior R&D Engineer will lead and execute complex R&D projects, contributing expert-level knowledge and delivering high-quality engineering outputs with minimal supervision.
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 generate key deliverables for a 510(k) regulatory submission, including:
CAD designs
Detailed print packages
Specification creation and rationale
Mapping specifications to essential design outputs
DFMEAs
Tolerance analyses
Device material assessments
Bill of materials
Provide technical guidance to product and technology teams
Evaluate feasibility and soundness of alternative engineering processes, products, or equipment
Coordinate, manage, and document project goals, progress, and recommended revisions
Develop and mentor others in engineering documentation best practices
Demonstrate strong PDP/TPD system knowledge through coaching and delivery of high‑impact, high‑quality outputs
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline
5+ years of experience in design assurance, new product development, or related work within the medical device or regulated industry
Proficiency in design controls, print packages, tolerance analysis, and GD&T
Strong problem‑solving mindset with a proactive, action‑oriented approach
Excellent verbal and written communication skills
Demonstrated experience using quality tools and methodologies
Ability to collaborate effectively in a hybrid onsite/remote environment
Proven ability to create detailed technical documentation
Preferred
Experience with medical devices, particularly catheters or delivery systems
Background in Quality Integration
Experience with 510(k) regulatory submissions
Knowledge of ISO 13485, ISO 14971, and Quality System Regulations, especially Design Controls and Risk Analysis
Strong facilitation and problem‑solving capabilities
Adaptable team player with the ability to work independently when needed
Experience with design changes, complaint reduction, and corrective actions
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase