An emerging medical device company based in Austin, Texas is currently seeking a Senior Engineering Manager.
The position leads the development of customized applications of the company’s core drug delivery platforms in conjunction with external customer technical and market requirements. Platform technologies include mechanically based, handheld drug delivery systems and aseptic unit dose blister packaging technology. You will be responsible for leading and managing a cross function engineering team to produce customized ophthalmic and intranasal drug/delivery systems entering early and late phase clinical trials. The qualified candidate will provide hands on engineering expertise, project management and interface with big pharma customers to produce FDA regulated drug delivery systems to be used by consumers for self administration of ophthalmic or intranasal prescription drugs. You will be responsible for engineering, design, process development, prototype development, verification/validation testing, and document control operating in a cGMP setting.
You will be responsible for ensuring successful on time, on budget delivery of delivery system customization projects through clinical trials. You will need excellent communication skills, project management skills and the ability to work in a collaborative atmosphere.
Responsibilities:
Actively participate in all phases of the product development process, from preliminary specification through transfer to clinical manufacture.
Define product requirements, communicate and resolve technical issues, and create and present project reviews and updates.
Effectively collaborate with cross-functional team members comprised of quality, manufacturing, marketing, clinical, regulatory, and materials people to bring product from conception to clinical production.
Follow FDA quality systems in Class I, and Class II 510(k) medical devices, 21 CFR 820 (QSR), and design control procedures including preparation of all required documentation.
Lead and manage project teams of engineers, designers and technicians to accomplish project objectives.
Experience/Qualification Requirements:
BS in related engineering or scientific discipline or equivalent. 12+ years of relevant technical experience with at least 5 years of engineering supervisory experience.
Possess strong knowledge of medical device engineering disciplines including a combination of materials, plastics/disposables engineering, multi-layered packaging laminate structures, aseptic pharmaceutical packaging, fluid dynamics, and solid knowledge of related disciplines such as biology and chemistry.
Direct experience with pharmaceuticals, particularly with respect to drug-device delivery interfaces and packaging is very desirable. Initiative and focus to drive projects from the development stage through commercialization.
Proven project management skills and experience, including design control procedures and Medical Device regulatory procedures. Knowledge of FDA regulatory and quality considerations in Class I and Class II 510(k) medical devices, 21 CFR 820 (QSR). Knowledge of GMP and QSR; familiarity with Design Controls and ISO guidelines.
Encourages effective alternative approaches to opportunities or problems. Inspires creativity and ideas from others. Capable of recognizing unusual patterns or relationships and can generate ideas that reflect technical competency and good business judgment.
Demonstrates expert skill and knowledge of techniques for motivating and facilitating individual and group decision-making. Coaches others through difficult decision-making situations. Has expert technical/functional/business knowledge.
Is able to produce educated and successful risk-taking. Inspires confidence, enthusiasm, and productivity in team members and co-workers and establishes a collaborative environment based on trust, open communication, and clear accountability.
Knowledge of plastics applications, associated tooling design, mold processing, and properties of plastics.
Hands-on experience with product development and design of electro-mechanical systems and formed and machined parts.
Experience with microfluidics or physical sciences, a strong plus.
Software Requirements:
Advanced skills in CAD (3-D solid modeling using SolidWorks), CAE, and Mechanical Engineering project management is required
Proficiency with the Microsoft Office suite including MS Project
Knowledge of COSMOSWorks, Mold Flow, MatLab, Labview, Fluent Computational Fluid Dynamics (CFD) is a plus
- Location: Austin, Texas
- Compensation: Commensurate with experience, health insurance, 401K and stock option plan
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