Device Development Lead, Associate Director
$154,400–$242,550 year
On-siteLexington, Massachusetts, United States
Job Summary
Lead device program execution by translating product strategy into actionable plans and delivering integrated development project plans across clinical development, registration, and commercialization. Build consensus within cross-functional teams to drive budgeting, resource deployment, and risk mitigation while ensuring alignment with Takeda's Stage Gate Milestone framework. Manage multiple program teams and represent the device development function at global governance bodies, including GPT and PDT leadership committees. Oversee quality assurance, regulatory compliance, and strategic planning for life cycle management and geographic expansion. Collaborate with commercial teams and external partners to align device strategy with market needs and launch readiness.
Required Qualifications
- BS/BEng in relevant engineering or scientific area of study
- minimum twelve (12+) years of relevant experience
- Relevant experience in device development and commercialization
- demonstrated success leading cross functional, global or enterprise-wide programs in the biotech/pharmaceutical or medical device industry
- demonstrated success leading multi-site, global or enterprise-wide programs in the medical device or biotech/pharmaceutical industry
- end-to-end development experience with capital equipment
- Proven Leader with ability to manage multiple complex cross-functional teams and processes
- Demonstrated experience managing programs in different stages of development in many therapeutic areas
- Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry
- Strong understanding of the relevant regulatory frameworks that govern devices across the product lifecycle
- Strong understanding of the business environment and relevant key strategic, operational drivers and competitive environment
- Excellent knowledge and application of elements of device-related product development and the relevant quality management systems
- Excellent knowledge and execution of subcontractor management and CMOs
- Strong understanding and competency in planning processes and decision making
- Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring
- Well versed with medical device product development process and FDA/EU MDR guidelines
- Familiar with Microsoft Project
- demonstrated versatility in operations / program management tools
- Able to translate strategies into tangible deliverables
- able to manage and resolve complex strategic and operational issues
- Lead device program teams by building consensus within the team and DPTs/GPTs
- Independent and creative thinker requiring minimum oversight
- A self-starter who is pro-active
- motivates
- has tact, diplomacy, true team player, and leadership skills
Desired Qualifications
- Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry is preferred
- Strong understanding of the relevant regulatory frameworks that govern devices across the product lifecycle
- Strong understanding of the business environment and relevant key strategic, operational drivers and competitive environment
- Excellent knowledge and application of elements of device-related product development and the relevant quality management systems
- Excellent knowledge and execution of subcontractor management and CMOs
- Strong understanding and competency in planning processes and decision making
- Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring
- Well versed with medical device product development process and FDA/EU MDR guidelines
- Familiar with Microsoft Project
- demonstrated versatility in operations / program management tools to facilitate functional and geographic collaboration and maximize team effectiveness
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