Staff Device Engineer

Takeda • Lexington, MA

14d

About The Position

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.

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
• A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO14971.
• Extensive knowledge of engineering principles, concepts and applications.
• Self-starter with strong planning and organizational skills.
• An aptitude for project foresight and contingency planning.
• Effective planning and organizational skills.
• Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences
• Strong knowledge of project management techniques, tools and metrics.
• Ability to mentor technical and cross functional team members.
• Strong collaboration skills with external partners.
• Develops and implements novel approaches and tools for data collection, management, engineering, analysis, modeling, and interpretation.
• Reviews, interprets data and communicates results with Pharm Sci functions and CMC team.
• Planning and implementation of solutions to project problem/issues
• Coordinates tech transfer with vendors.
• Stays updated on related technologies/methodologies and proposes options to implement within area of expertise
• Drive the evaluation of complex drug delivery systems and provide sound technical recommendations to move projects forward.
• Identify, communicate and lead device design control process evolution to meet device regulations.
• Collaborate with commercial Product teams, Quality, Mfg, Regulatory, R&D, Clinical, Legal
• Work closely with Contract Lab Organizations (CLOs), Contract Manufacturing Organizations (CMOs)
• Communicates activities from their functional area to project teams (pipeline, non-pipeline, and functional initiatives) and requests functional area action from the project teams to senior leaders in their functional area.
• Has authority as a technical project leader to commit available resources to execute specific project tasks for project teams (pipeline, non-pipeline, and functional initiatives) upon request
• May fully represent their functional area to a project teams (pipeline, non-pipeline, and functional initiatives with narrow focus)
• May identify topics for functional initiatives
• Work closely with external design, development and manufacturing partners
• Functional training for multiple laboratory technologies: Develops and uses basic knowledge of cross functional departments to guide junior colleagues on impact of changes and inter- dependencies.
• Develops expertise in multiple laboratory technologies and leverages as functional area resource and trainer.
• May have responsibility for training/mentoring of junior colleagues

Nice To Haves

• 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 a plus.
• Proven track record of developing and gain regulatory approval of drug delivery systems a plus
• Working knowledge of solid works desirable.

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.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees