Device Engineer

Job Description

Staff Device Engineer at Bio Space

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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 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. Focus areas include user‑need identification, specification development, prototyping, test development, design verification and validation testing, risk assessment, and equipment development oversight.

Extensive collaboration occurs with internal and external partners.

This role also supports a team of device engineers responsible for the technical aspects of life‑cycle management of commercialized combination products, medical devices, and pre‑filled syringes. The Staff Device Engineer works cross‑functionally to support lifecycle management of commercial combination products, and has extensive experience in medical devices for drug delivery, polymeric medical device manufacturing processes (molding and assembly), and global standards for combination products.

Key responsibilities include change controls, manufacturing process validation, device product complaints, regular review of DHF, and post‑market surveillance. Interaction occurs with external CROs, CMOs, vendors, and internal drug product, quality, regulatory, and program leadership.

• Plans and coordinates work with departmental and cross‑functional peers, defining risks and recommending contingency plans.
• Evaluates impact of decisions across CMC functions.
• Contributes significantly to complex pipeline or functional area projects, often across multiple projects.
• Designs, executes, and reports results independently; proactively analyzes manufacturing issues and coordinates solutions with the CMC team.
• Coordinates support of specific technical issues related to projects.
• Tries to address issues during or resulting from manufacturing.
• Provides technical leadership on cross‑functional teams for devices through clinical development, product registration, and commercialization; owns design control deliverables to comply with medical device and combination device regulations.
• Leads project execution activities and oversees development of statistically sound design verification protocols/reports and design validation.
• Establishes and fosters strong collaborative relationships with external design, development, manufacturing partners, and service providers.
• Leads or assists in deviation, complaint, and failure investigations.

• Bachelor’s degree and 8+ years relevant industry experience, or master’s degree and 6+ years, or PhD and 0+ years in 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), ISO 13485, and ISO 14791 requirements.
• Knowledge of global industry standards (e.g., ISO, AAMI, ANSI).
• 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 experience leading & supporting projects that include managing external design, development, and manufacturing partners.
• Prior technical leadership experience with creating design control/technical file deliverables and manufacturing scale‑up is a plus.
• Proven track record of developing and obtaining regulatory approval of drug delivery systems is a plus.
• Working knowledge of Solid Works desirable.

• Strong knowledge of developing and commercializing…