Lead Disposables R&D Engineer (Hybrid)

Vantive; Plymouth (MN); Vor Ort; USD 108.000 - 149.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) plan

Flexible spending accounts

Paid time off

Parental leave

Commuting benefits

Zusammenfassung

Vantive is seeking a lead engineer to design and develop product changes for disposable medical devices within our NPD team. You will manage projects, mentor staff, and ensure compliance with design controls.

You will collaborate with global stakeholders, apply risk management methods, and contribute to IP through disclosures and patent applications. The role requires 5-8+ years of disposables experience and strong CAD skills.

Qualifikationen

• BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred.
• 5-8+ years in Class II/III disposables medical product development.
• Advanced plastics materials & processing knowledge (injection molding, extrusion, welding, bonding, sterilization).
• Advanced knowledge of FDA Design Controls and ISO 13485 QMS.
• CAD design and PDM software experience (Creo, SolidWorks).
• Knowledge of ANSI/AAMI/ISO 14971 Risk Management.
• Creative problem solver; identify risks early and drive mitigations.
• Initiative with learning, innovation, and continuous improvement.
• Ability to train and coach others.
• Self-directed and able to manage multiple priorities.
• Strong interpersonal, communication, collaboration and influencing skills.
• Ability to read, write and comprehend English.

Aufgaben

• Schedule, budget, and lead engineering projects with minimal guidance.
• Serve as the technical expert for design change programs (new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
• Identify, investigate, and solve complex engineering problems using risk-based and customer-focused approaches (dFMEA, Human Factors Engineering, stats, CAD).
• Lead the creation and maintenance of design history files.
• Coordinate and communicate R&D efforts with global cross-functional stakeholders.
• Adhere to design control procedures, safety rules, policies and FDA/international guidance.
• May supervise engineers and/or technicians.
• Contribute to intellectual property through invention disclosures and patent applications.

Kenntnisse

Plastics processing

FDA Design Controls

CAD/PLM

Risk Management

Problem solving

Self-motivation

Mentoring

Collaboration

English proficiency

Ausbildung

Bachelor's degree in Mechanical/Plastics/Biomedical Engineering

Master's degree preferred

Tools

Creo

SolidWorks

Jobbeschreibung

Vantive is seeking a lead engineer to design and develop product changes for disposable medical devices within our NPD team. You will manage projects, mentor staff, and ensure compliance with design controls.

You will collaborate with global stakeholders, apply risk management methods, and contribute to IP through disclosures and patent applications. The role requires 5-8+ years of disposables experience and strong CAD skills.