Senior Medical Device R&D Engineer – Sustaining & Design

Actalent; Plymouth (MN); Hybride; USD 88 000 - 121 000; Plein temps

Résumé du poste

Actalent in Plymouth, MN is seeking a Mechanical/ Biomedical Engineer to support design changes for Class II/III disposable medical devices within a sustaining engineering environment. You will drive device improvements, verify performance, and ensure regulatory compliance with FDA and ISO standards.

Responsibilities include developing test methods, creating design docs, collaborating across functions, and contributing to CAPA and risk management initiatives.

Qualifications

• Bachelor's degree in Mechanical, Plastics, Biomedical Engineering, or related field.
• 3+ years of experience with Class II/III disposable medical devices.
• Experience with sustaining engineering and change management.
• Knowledge of plastics manufacturing: injection molding, extrusion, bonding, sterilization.
• Proficiency with CAD tools such as Creo or SolidWorks.
• Understanding of FDA Design Controls, ISO quality systems, and medical device risk management.
• Strong problem-solving, communication, and project management skills.

Responsabilités

• Lead and support design changes for disposable medical devices, including materials, suppliers, features, labeling updates, CAPA actions, and cost reduction initiatives.
• Develop and execute test methods, product testing, and verification/validation activities.
• Create and maintain design documentation, specifications, drawings, protocols, and reports.
• Apply risk management tools, dFMEA, Human Factors Engineering, and statistical analysis to solve engineering challenges.
• Design and build prototypes, tooling, fixtures, and test equipment as needed.
• Use CAD tools (Creo/SolidWorks) to develop and maintain product designs.
• Collaborate with cross-functional teams to ensure projects are completed on time and in compliance with FDA and ISO requirements.
• Support continuous improvement initiatives and best practices within R&D and sustaining engineering.

Connaissances

CAD experience

Project management

Problem solving

Communication

Formation

Bachelor's in Mechanical/ Biomedical Eng

Outils

Creo/SolidWorks

Description du poste

Actalent in Plymouth, MN is seeking a Mechanical/ Biomedical Engineer to support design changes for Class II/III disposable medical devices within a sustaining engineering environment. You will drive device improvements, verify performance, and ensure regulatory compliance with FDA and ISO standards.

Responsibilities include developing test methods, creating design docs, collaborating across functions, and contributing to CAPA and risk management initiatives.