Takeda · 23 hours ago
Staff Device Engineer
Lexington, MA
Full-time
Onsite
Senior Level, Lead/Staff
$112K/yr - $176K/yr
6+ years expTakeda is a company focused on developing innovative medicines, and they are seeking a Staff Device Engineer to lead technical efforts for combination products and drug delivery device projects. The role involves providing project and engineering leadership throughout various phases of device development, ensuring compliance with global standards and fostering collaboration with internal and external partners.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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
Qualification
Required
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
Preferred
Design for Six Sigma (DFSS) certification is desirable
Working knowledge of solid works desirable
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
Benefits
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
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-14
Pharmaceutical Technology
2026-01-11
Company data provided by crunchbase