Principal Materials Engineer (Combination Devices)

Medtronic•Mounds View, MN

6d•Onsite

About The Position

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.

Requirements

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
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

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

Responsibilities

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 21CFR 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

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)