49 applicantsPosted by Agency

Company

ACE Partners · 1 day ago

Senior Principal R&D Engineer

United States

Full-time

Remote

Senior Level, Lead/Staff

$150K/yr - $170K/yr

12+ years exp

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Hiring Manager

Thomas Hatfield

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Responsibilities

Lead design control activities, including planning, verification/validation, and documentation, throughout product development.

Oversee project timelines, budgets, risk management, and communication with executive stakeholders.

Direct non-clinical testing, including test plan creation, execution, and analysis.

Collaborate with cross-functional teams and external suppliers to ensure alignment in product development and manufacturing processes.

Mentor junior engineers and foster team development.

Conduct prototype design, testing, and evaluation to address technical challenges and optimize device performance.

Develop intellectual property and contribute to regulatory and quality documentation.

Qualification

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Mechanical EngineeringBiomedical EngineeringClass III cardiovascular devicesDesign controlsRisk managementRegulatory requirementsFEAMaterial testingCAD (SolidWorks)Statistical analysis toolsManufacturing processesRegulatory submissionsFatigue testingDurability testingISO standardsVitro testingSitu testingVivo testingTechnical writingTechnical leadershipCross-functional collaboration

Required

Bachelor’s degree in Mechanical or Biomedical Engineering (MS/PhD preferred) with 12+ years of relevant experience.

Expertise in Class III cardiovascular devices, including endovascular stent grafts and delivery systems.

Strong understanding of design controls, risk management, and regulatory requirements (FDA IDE/PMA, EU MDR, etc.).

Proficiency in FEA, material testing, CAD (SolidWorks), and statistical analysis tools like Minitab.

Knowledge of manufacturing processes such as polymer shrinking, laser bonding, and braiding.

Exceptional technical and communication skills, with experience in technical writing and regulatory submissions.

Preferred

Experience with fatigue and durability testing for implantable devices.

Knowledge of standards like ISO 62366, ISO 10993, and IEC 60601.

Hands-on experience with in vitro, in situ, and in vivo testing for cardiovascular applications.

Company

ACE Partners

ACE Partners is a recruitment firm dedicated to sourcing top talent for the US manufacturing sector, focusing on maintenance, regulatory and clinical affairs roles.

Founded in 2020

Manchester, GB

2-10 employees