Staff Device Engineer

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Job Description

Primary Role:

The Staff Device Engineer will lead technical efforts for combination products and drug delivery device projects with limited oversight. As a hands-on technical lead/contributor and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive collaboration with internal and external partners.

This role supports as well a  team of device engineers responsible for all the technical aspects of life cycle management of commercialized Combination Products,  Medical Devices and pre-filled syringe  among others. This role works with cross functional team to support lifecycle management of commercial combination product.

The Staff Device Engineer has extensive experience in medical devices for drug delivery including combination products, solid understanding of polymeric medical device manufacturing processes via molding and assembly, and solid knowledge of global standards for the combination products.

This key technical role is responsible for change controls, manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role interacts with external CLO and CMO and vendors, works closely with drug product, quality, regulatory, program leadership, etc.  and establish strategic working relationships.

Responsibilities:

• Plans and coordinates work with departmental and cross functional peers (within and outside Pharm Sci) with an understanding of project timelines/deliverables and define risks and recommend contingency plans as required.

• Evaluates impact of decisions across CMC functions.

• Makes significant independent contributions to complex pipeline or functional area project. May significantly contribute to more than one project within functional area.

• Independently designs, executes and reports results. Proactively analyses manufacturing issues and coordinates potential solutions with the CMC team. Assists in the technical aspects of negotiation with vendors.

• Coordinates support of specific technical issues related to projects

• May proactively address issues during or resulting from manufacturing.

• Provide technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device and combination device regulations.

• Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation.

• Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.

• Lead or assist in deviation, complaint and failure investigations.

Education and Experience Requirements:

• Bachelor’s degree and 8+ years relevant industry experience or master’s degree and 6+ years relevant industry experience, or PhD and 0+ years in the  field of combination product or medical device development and commercialization is desired.

• Minimum of 6 years leading cross functional teams and projects. Hands on technical support and lab skills for measurement using various instruments required

• Experience supporting regulated devices / combination products under Design Control (21 CFR 820), ISO13485, and ISO14791 requirements.

• Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc.).

• Hands on technical leadership skills with a track record of supporting on- the market products and delivering new products to market

• Design for Six Sigma (DFSS) certification is desirable.

• Prior