Principal Materials Engineer (Combination Devices

We anticipate the application window for this opening will close on - 31 Aug 2026 Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.

Journée type The Electrophysiology Therapies (EPT) group is looking for their next Principal Materials Engineer within the Cardiac Rhythm Management (CRM) operating unit. EPT offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. This role will serve as an expert in combination devices by participating in technical activities for materials selection, processing, analysis, biostability, and process-property-performance relationships for medical devices.

Additionally, this role will serve as a combination specialist with an emphasis on polymers and pharmacological applications, pharmacokinetics, and drug elution, informing current product strategy, product roadmap, and risk burndown. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

In general, the following responsibilities apply for the Principal Materials Engineer (Combo Devices) role. This includes, but is not limited to the following:
Provide expertise in the following business-critical skill sets:

• Device-drug combination product support, development, and regulations
• Device-drug combination product characterization test methodologies
• Be familiar with pharmaceutical test method validation, procedures and associated analytical test requirements
• Be familiar with regulatory requirements around bioavailability and bioequivalence
• Utilize ICH, USP/EP, and 21
  
  CFR Part 211/212 and Part 820
• Utilize basic pharmacodynamics and pharmacokinetics principles (AUC, tmax, Cmax, t1/2)
• Coordinate and conduct laboratory work and data analysis to drive data-driven technical decisions
• Utilize formulation development for combination products
• Design benchtop testing and preclinical studies; understand requirements for a GLP preclinical study
• Support postmarket design changes, manufacturing support, operational troubleshooting, and CAPA support
• Integrate product development and characterization testing into quality system and design controls;
  Be familiar with Design Verification and Design Validation requirements

• Expertise in materials with the ability to identify and develop testing methods, correlate material properties with product performance, and predict various failure modes
• cGMP experience
• Experience supporting product scaleup and launch
• Knowledge of external standards, e.g., ICH, ASTM and ISO, and their use, limitations, and applications
• Demonstrated ability to apply skills and knowledge of technical/operational theories and principles to resolve real-world biomaterials challenges
• Knowledge of statistical methods and Design of Experiments (DoE) using Minitab, JMP, or other statistical software

7+ years of relevant experience with a bachelor’s degree OR 3+ years of relevant experience with an advanced degree in chemistry, material science, chemical engineering, polymer science, or related field

Pour les diplômes de baccalauréat obtenus en dehors des États-Unis, un diplôme qui satisfait aux exigences de la réglementation 8 C.F.R. § 214.2 (h) (4) (iii) (A) est requis.

Exigences physiques du poste Les déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste. Les exigences…