Advantage Technical · 13 hours ago
Research Development Mechanical Engineer
Arden Hills, MN
Full-time
Hybrid
Mid Level
$58/hr - $58/hr
4+ years expAdvantage Technical is seeking a highly skilled Mechanical Engineer for their Urology Research & Development organization. The role focuses on integrating an acquired company’s Design History File into Boston Scientific’s Quality System to ensure FDA compliance, primarily through design remediation and verification activities.
Staffing & Recruiting
No H1B
Hiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Assess the acquired company’s Design History File (DHF) against Boston Scientific work instructions and SOPs to identify gaps
Develop and execute strategies to close gaps related to:
Design inputs and outputs
Risk management and DFMEA
Design verification testing
Test method development and validation
Requirements traceability
Design, execute, and document verification and validation testing, including protocols, reports, and rationales
Design new test methods and duplicate testing between California and Minnesota sites as needed
Communicate progress, risks, tradeoffs, and technical recommendations to project leadership
Provide technical solutions with guidance from subject matter experts
Deliver high-quality engineering documentation that meets Boston Scientific and FDA requirements
Demonstrate strong knowledge of product development and technology development systems
Qualification
Required
Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or a related field
4+ years of medical device engineering experience
(2+ years with a Master's degree)
Prior medical device industry experience is required
Strong mechanical and/or systems engineering skills with excellent attention to detail
Experience in design verification, test method development, and test method validation
Ability to synthesize technical inputs from multiple sources and make sound engineering recommendations
Strong written and verbal communication skills
High sense of ownership, accountability, and bias for action
Must be authorized to work in the U.S. without visa sponsorship now or in the future
Preferred
Experience in urology devices and/or active implantable medical devices
Familiarity with applicable standards: IEC 14708 (Active Implantable Medical Devices), IEC 45502, IEC 60601 (Medical Electrical Equipment)
Experience with statistical analysis tools and methods (e.g., Minitab, Gauge R&R, process capability studies)
DMAIC or structured problem-solving experience
Experience developing and validating test methods for active implantable or single-use devices
Ability to build strong relationships across cross-functional teams and external partners
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase