Advantage Technical · 23 hours ago
Senior Research And Development Engineer
Maple Grove, MN
Full-time
Hybrid
Senior Level
5+ years expAdvantage Technical is seeking a Senior Research And Development Engineer who will conduct development work on major research initiatives. The role involves collaborating with a team to develop new products and providing technical guidance while managing project goals and timelines.
Staffing & Recruiting
No H1B
Hiring Manager
Damarys Zambrano, MSIOP
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 supporting a 510(k) regulatory submission, including but not limited to:
CAD designs and detailed drawing/print packages
Design specifications, rationales, and specification mapping to essential design outputs
DFMEAs, tolerance analyses, and GD&T
Device material assessments and bills of materials (BOMs)
Provide technical guidance and mentorship to product development and technology teams
Assess the feasibility and technical soundness of alternative engineering processes, products, and equipment
Coordinate, manage, and document project goals, timelines, and progress; recommend and implement revisions as appropriate
Develop, review, and coach team members on high-quality engineering documentation
Demonstrate strong knowledge of PDP/TPD systems through coaching and delivery of high-impact, compliant design deliverables
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline
Minimum of 5 years of experience in design assurance, new product development, or a regulated industry (medical device preferred)
Strong experience with design controls, print packages, tolerance analysis, and GD&T
Demonstrated ability to create detailed technical documentation
Proven use of quality tools and methodologies
Self-motivated problem solver with a strong bias for action
Excellent verbal and written communication skills
Ability to collaborate effectively in a hybrid onsite/remote work environment
Preferred
Experience with medical devices, particularly catheter or delivery systems
Quality integration experience
Hands-on experience supporting 510(k) regulatory submissions
Working knowledge of ISO 13485, ISO 14971, and Quality System Regulations, with a focus on Design Controls and Risk Management
Experience leading structured problem-solving activities
Ability to work effectively both independently and within cross-functional teams
Experience supporting design changes, complaint reduction initiatives, and corrective actions (CAPA)
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase